Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-08-11 | NAI | No action indicated | Precision Spine Inc | 0 |
Similar devices
- ATTUNE FEMORAL IMPACTOR ENZTEC LIMITED
- 3.8 CS Strike Pin INTERVENTIONAL SPINE, INC
- 3S Hemi Trilliant Surgical, LLC
- 3S Hemi Trilliant Surgical, LLC
- 3S Hemi Trilliant Surgical, LLC
- A-SPACE SIBD Aesculap AG
- ACCESSORY CONN. M10 HPF SRL
- ACCESSORY CONN. M8 HPF SRL
- ACCESSORY CONN. M8x1 HPF SRL
- ACCESSORY SCREWDRIVER HPF SRL
- ACCESSORY TRACKER HPF SRL
- ACETABULAR RIM PUNCH Biomet Orthopedics, LLC
Select up to two to place side-by-side with this device.