FDA Adverse Event
Injury
Summary report: N
BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT
MDR report key: 24576920
·
Received March 12, 2026
Report
- Report Number
- 3020652-2026-00001
- Event Type
- Injury
- Date Received
- March 12, 2026
- Report Date
- March 11, 2026
- Manufacturer
- MIACH ORTHOPAEDICS
- Product Code
- QNI
- UDI-DI
- 00860002987804
- PMA / PMN Number
- K251214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER IMPLANT.
Description of Event or Problem · 0
PATIENT STATES: I HAD AN ACL REPAIR WITH BEAR IMPLANT AND HAD SEVERE ALLERGIC REACTION THAT REQUIRED A LOA AND A REMOVAL OF ACL.DATE OF SURGERY NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638732 | BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT | Resorbable implant for anterior cruciate ligament (ACL) repair | QNI | MIACH ORTHOPAEDICS | 00860002987804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |