Scorecard
Events per device across the 1,169-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.008 ▼
9 in the last 12 months
Higher volume than 86% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
1,169 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|
| KONG-TL VBR System, Screwdriver for Locking Screw | 44-050 | MQP PLR | 07640164847849 | 16 |
| icotec Pedicle System, Nut Screw, Ti | 16-57-41000 | NKB PML | 07640140431994 | 12 |
| VADER Pedicle System, Nut Screw, Ti | 16-57-41000 | NKB PML | 07640172554227 | 10 |
| VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, TL1, Ø 6.0 x 300 mm | 16-60-2MC30-3 | NKB PML | 07640172551738 | 6 |
| VADER Pedicle System, Torque Wrench, Hudson Coupling, 12 Nm | 42-702 | NKB | 07640164844589 | 6 |
| KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mm | 12-91-1922-9 | MQP PLR | 07640164847412 | 5 |
| KONG®-TL VBR System Screwdriver for Locking Screw | | | | 4 |
| VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 45 mm | 16-6022-57545 | NKB PML | 07640164844817 | 3 |
| VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 200 mm | 16-60-24520 | NKB PML | 07640172551905 | 2 |
| VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 45 mm | 16-6022-55545 | NKB PML | 07640164844671 | 2 |
| VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 50 mm | 16-6022-56550 | NKB PML | 07640164844756 | 2 |
| icotec Ant. Cervical Plate, 3 Segmental, 61 mm | 12-73-18-61 | KWQ | 07640140438320 | 2 |
| "VADER Pedicle System, T-Handle, Ratchet (Push-Mechanism), 1/4"" Coupling" | 42-733 | NKB | 07640172552117 | 1 |
| "icotec Systems, Handle, 1/4"" Coupling" | 42-892 | NKB NKG OLO PML | 07640172553848 | 1 |
| KONG-C VBR System, Drag Pointer | 43-040-1 | MQP PLR | 07640172551387 | 1 |
| KONG-C VBR System, Footprint Trial 18, 18x14 mm | 43-061 | MQP PLR | 07640172550632 | 1 |
| KONG-C VBR System, Height Forceps | 43-040 | MQP PLR | 07640172550069 | 1 |
| KONG-C VBR System, Impactor | 43-050 | MQP PLR | 07640172550656 | 1 |
| KONG-C VBR System, Inserter Rod | 43-020 | MQP PLR | 07640172550649 | 1 |
| KONG-C VBR System, Inserter Sleeve | 43-010 | MQP PLR | 07640172550045 | 1 |
| KONG-C VBR System, KONG-C VBR M, Container Base | 43-090-1 | MQP PLR | 07640172550939 | 1 |
| KONG-C VBR System, KONG-C VBR M, Container Inlay | 43-090-3 | MQP PLR | 07640172550953 | 1 |
| KONG-C VBR System, KONG-C VBR M, Container Lid | 43-090-2 | MQP PLR | 07640172550946 | 1 |
| KONG-C VBR System, KONG-C VBR M, Container, complete | 43-090 | MQP PLR | 07640172550076 | 1 |
| KONG-C VBR System, Screwdriver | 43-030 | MQP PLR | 07640172550052 | 1 |
| KONG-C VBR System, Trial Body, 16 mm | 43-216 | MQP PLR | 07640172550670 | 1 |
| KONG-C VBR System, Trial Body, 18 mm | 43-218 | MQP PLR | 07640172550687 | 1 |
| KONG-C VBR System, Trial Body, 20 mm | 43-220 | MQP PLR | 07640172550694 | 1 |
| KONG-C VBR System, Trial Body, 22 mm | 43-222 | MQP PLR | 07640172550700 | 1 |
| KONG-C VBR System, Trial Body, 24 mm | 43-224 | MQP PLR | 07640172550717 | 1 |
Showing 1–30 of 1,169Next → Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|
| 3006493760 | ICOTEC AG | Altstaetten Sankt Gallen, CH | — | |