FDA Adverse Event
Malfunction
Summary report: N
BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT
MDR report key: 22965578
·
Received September 4, 2025
Report
- Report Number
- 3020652-2025-00023
- Event Type
- Malfunction
- Date Received
- September 4, 2025
- Date of Event
- July 8, 2024
- Report Date
- September 3, 2025
- Manufacturer
- MIACH ORTHOPAEDICS
- Product Code
- QNI
- UDI-DI
- 00860002987804
- PMA / PMN Number
- K243578
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE IMPLANT WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT AND THE PROCEDURAL OUTCOME WAS FINE.
Description of Event or Problem · 0
DRS CASE ON MONDAY HE HAD A COMPLAINT REGARDING HOW RAPIDLY THE IMPLANT TOOK ON BLOOD, BECOMING MUSH IN ONLY A FEW SECONDS. HE ASKED IF I COULD MENTION SOMETHING TO QUALITY CONTROL AS HE HAS NOT SEEN AN IMPLANT ABSORB BLOOD THIS QUICKLY THUS FAR IN HIS EXPERIENCE WITH BEAR. THE IMPLANT WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT AND THE PROCEDURAL OUTCOME WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1675794 | BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT | Resorbable implant for anterior cruciate ligament (ACL) repair | QNI | MIACH ORTHOPAEDICS | 7010531 | 00860002987804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |