FDA Adverse Event
Malfunction
Summary report: N
BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT
MDR report key: 22966475
·
Received September 4, 2025
Report
- Report Number
- 3020652-2025-00025
- Event Type
- Malfunction
- Date Received
- September 4, 2025
- Date of Event
- April 17, 2025
- Report Date
- September 3, 2025
- Manufacturer
- MIACH ORTHOPAEDICS
- Product Code
- QNI
- PMA / PMN Number
- K243578
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PROCEDURE WAS COMPLETED ON (B)(6) 2024. FOLLOW UP VISITS WITH THE SURGEON NOTED THAT THE ACL APPEARED TO BE INTACT BUT COULD NOT EXPLAIN THE PAIN.
Description of Event or Problem · 0
ON (B)(6) 2025, THE FEMALE PATIENT REACHED OUT TO INDICATE ONGOING PAIN IN THE BACK AND SIDES OF HER KNEE. FOLLOW UP VISITS WITH THE SURGEON NOTED THAT THE ACL APPEARED TO BE INTACT BUT COULD NOT EXPLAIN THE PAIN. AN MRI OF THE KNEE WAS COMPLETED AND THE PATIENT INDICATED THE IMPLANT FAILED. MRI IMPRESSION NUMBER 2 STATES: "IRREGULAR APPEARANCE OF THE LATERAL MENISCUS IS AGAIN NOTED, SUGGESTING TEARING AND/OR POSTOPERATIVE CHANGES. FURTHER DIFFERENTIATION IS LIMITED DUE TO PAUCITY OF FLUID IN THE JOINT SPACE.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2081276 | BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT | Resorbable implant for anterior cruciate ligament (ACL) repair | QNI | MIACH ORTHOPAEDICS | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |