Materialise NV
156 adverse events · 54 clearances · aggregated across 2 source records
Scorecard
Events per device across the 593-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.030 ▼
18 in the last 12 months
Higher volume than 90% 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
593 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| TruMatch | SD980.016 | JEY | 05420060380167 | 173 |
| TruMatch | SD980.014 | JEY | 05420060380143 | 60 |
| TruMatch | SD980.001 | JEY | 05420060380013 | 59 |
| TRUMATCH | SD980.108 | JEY | 05420060381089 | 36 |
| TruMatch | SD980.020 | JEY | 05420060380204 | 25 |
| TRUMATCH | SD980.109 | JEY | 05420060381096 | 19 |
| TruMatch | SD980.021 | JEY | 05420060380211 | 15 |
| TruMatch | SD980.003 | JEY | 05420060380037 | 12 |
| TruMatch | SD980.017 | JEY | 05420060380174 | 10 |
| ProPlan CMF | SD900.008 | HWT | 05420060350573 | 9 |
| TruMatch | SD980.005 | JEY | 05420060380051 | 9 |
| Zimmer Patient Specific Instruments | 00-5970-000-10 | HSX JWH | E314005970000100 | 8 |
| ProPlan CMF | SD900.105 | HWT | 05420060351150 | 7 |
| ProPlan CMF | SD900.008 | HWT | 05420060355080 | 6 |
| ProPlan CMF | SD900.101 | JEY | 05420060351013 | 4 |
| ProPlan CMF | SD900.105 | HWT | 05420060355059 | 4 |
| ProPlan CMF | SD900.106 | HWT | 05420060351167 | 4 |
| TRUMATCH | SD980.107 | JEY | 05420060381072 | 4 |
| AtlasPlan | SHC-IN03-02-01 | KWS PHX QHE | 05420060367052 | 3 |
| AtlasPlan | SHC-IN03-00-01 | KWS PHX QHE | 05420060367069 | 3 |
| AtlasPlan | SHC-IN04-00-01 | KWS PHX QHE | 05420060367083 | 3 |
| AtlasPlan | SHC-IN04-01-01 | KWS PHX QHE | 05420060367090 | 3 |
| AtlasPlan | SHC-IN04-02-01 | KWS PHX QHE | 05420060367106 | 3 |
| AtlasPlan | SHC-IN03-01-01 | KWS PHX QHE | 05420060367076 | 3 |
| AtlasPlan | SHC-IN05-00-01 | KWS PHX QHE | 05420060367120 | 3 |
| Materialise Personalized Solutions | O-01-0-105000-0011-010 | PBF | 05420060343285 | 3 |
| ProPlan CMF | SD900.102 | JEY | 05420060351020 | 3 |
| SurgiCase | O-01-0-105000-0011-010 | PBF | E314O01010500000110100 | 3 |
| SurgiCase Planner | SurgiCase Knee Planner | HSX JWH MBH OIY OOG | 05404028000922 | 3 |
| SurgiCase Planner | SurgiCase Knee Planner | HSX JWH MBH OIY OOG | E314SURGICASEKNEEPLAN0 | 3 |
Showing 1–30 of 593Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
No registered facilities linked.