PRECISION SPINE, INC.
401 adverse events · 26 clearances · 1 inspections · aggregated across 2 source records
Scorecard
Events per device across the 7,958-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.005 ▼
43 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
7,958 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Reform Pedicle Screw System | 39-RD-0060 | HXX | 00840019928366 | 328 |
| SureLOK MIS 3L | 63-SP-9005 | LXH | 00840019920179 | 58 |
| Reform Ti CT Modular MIS Pedicle Screw System | 64-MT-0403 | KWP MNH MNI NKB OSH | 00840019940610 | 48 |
| Vault C ACDF System | 37-IN-0060 | HXX | 00840019916974 | 36 |
| Reform Pedicle Screw System | HXX-39-0001 | HXX | 00840019928809 | 34 |
| Reform Pedicle Screw System | 39-SP-0700 | HXX | 00840019928731 | 29 |
| Reform Pedicle Screw System | 39-SP-0601 | HXX | 00840019928700 | 26 |
| Reform Ti Modular | 39-MT-0401 | KWP MNH MNI NKB OSH | 00840019932622 | 10 |
| Intervertebral Body Fusion Device | 10-P3208-13P | OVD | 00840019908474 | 9 |
| Reform TI Pedicle Screw System | 39-SB-6545 | KWP MNH MNI NKB OSH | 00840019931953 | 9 |
| Reform Pedicle Screw System | 39-SP-0730 | HXX | 00815362022016 | 9 |
| Reform Ti CT Modular MIS Pedicle Screw System | 64-SP-1700 | HXX | 00840019942454 | 9 |
| Anterior Lumbar Plate System | ALP-35HS | HXX | 00840019925556 | 8 |
| Vault C ACDF System | 37-HP-0400 | HXX | 00840019917100 | 8 |
| PSS System | SLP4540 | KWP MNH MNI | 00840019913492 | 7 |
| Reform Ti CT Modular MIS Pedicle Screw System | 64-RD-9010 | LXH | 00840019942515 | 7 |
| Reform Ti HA Coated Pedicle Screw | 39-HT-7535 | KWP MNH MNI NKB OSH | 00815362029190 | 7 |
| Reform Ti Modular | 39-SK-6545 | KWP MNH MNI NKB OSH | 00840019933629 | 7 |
| Intervertebral Body Fusion Device | 10-P3215-13P | OVD | 00840019908528 | 6 |
| NexGen Anterior Cervical Plate System | 65-DF-4016 | KWQ | 00840019932790 | 6 |
| Reform TI Pedicle Screw System | 39-SG-5550 | KWP MNH MNI NKB OSH | 00840019940078 | 6 |
| Reform Ti Modular | 39-SP-0750 | HXX | 00840019932455 | 6 |
| ShurFit Interbody Device | TLIF30-08P | KWQ MAX | 00840019909907 | 6 |
| ShurFit Interbody Device | ALIF0832-11P | KWQ MAX | 00840019912075 | 6 |
| ShurFit Lumbar Interbody | 72-IN-1001 | LXH | 00840019960403 | 6 |
| ShurFit MALIF System | 23-9029-03 | LXH | 00840019925310 | 6 |
| SureLOK MIS 3L | 63-CP-6540 | MNH MNI | 00840019905503 | 6 |
| Reform MC Screw System | 59-SP-0601 | HXX | 00840019927987 | 5 |
| Reform Ti Modular | 39-SK-6540 | KWP MNH MNI NKB OSH | 00840019933612 | 5 |
| SureLOK MIS 3L | 63-4100-55 | HWX | 00840019920063 | 5 |
Showing 1–30 of 7,958Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
No registered facilities linked.