MalfunctionQNI
BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT
Received Sep 4, 2025 · Event occurred Dec 28, 2022
Report 3020652-2025-00010 · MDR key 22964131
Device
Generic name
Resorbable Implant For Anterior Cruciate Ligament (acl) Repair
Manufacturer
Miach OrthopaedicsCatalog number
1000
Lot number
7008409
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SECOND IMPLANT. PATIENT IS DOING WELL.
Description of Event or Problem
WHEN OPENED FROM POUCH, IT WAS DIFFICULT TO DISCERN TOP OF IMPLANT FROM BOTTOM (BASE). BEAR IMPLANT HYDRATED VERY FAST AND FELL APART WHEN ATTEMPTING TO PUT IN KNEE. IMPLANT WAS DISCARDED AND PROCEDURE WAS COMPLETED WITH A SECOND IMPLANT. SECOND IMPLANT LOOKED BETTER AND HYDRATED NORMALLY AND WAS FROM THE SAME LOT.