MAUDE Adverse Event Report: MIACH ORTHOPAEDICS BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT; Resorbable implant for anterior cruciate ligament (ACL) repair

Catalog Number	1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Cartilage damage (4833); Limb Pain (4836)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient provided surgeon reports that do not substantiate the patient's claims that the bear implant "was informed that the bear implant had not been entirely successful and had caused secondary damage to my cartilage, leading to the development of arthritis".The post surgery report dated (b)(6) 2023 indicate the acl is "intact" and "in satisfactory alignment".The second surgery report dated (b)(6) 2023 indicated that the patient had a right knee medial meniscus tean and the acl is intact while indicating that the patient may have some recurrent tearing of his medial meniscus.The operative findings identified the acl as "overall intact".Postoperative changes of prior acl repair/augmentation.Acl fibers are somewhat indistinct and irregular likely representing a component of healing/scarring.No fluid filled defect to suggest recurrent tear.The post surgery reports indicate that the bear implant performed as intended and there were no product defects.
Event or Problem Description
Patient emailed the customer service team on (b)(6) 2025 to "asking for a resolution/guidance for my bear implant case".In (b)(6) 2022 the patient tore their right knee acl and meniscus.The patient traveled from (b)(6) texas, where the orthopaedic surgeon performed the acl bear implant procedure and also repaired their meniscus on (b)(6) 2022.11 months post-surgery, the patient reported that my knee had not improved.At that time, he was recommended to get an mri.In (b)(6) 2023, the patient underwent a second surgery and resumed physical therapy immediately afterward.The patient claims that they were informed that the bear implant had not been entirely successful and had caused secondary damage to my cartilage, leading to the development of arthritis.The patient visited a surgeon in mayo clinic, sport center.They performed an extensive evaluation of their knee.An mri and x-rays revealed that my bear acl implant had nearly failed, with only the implant's strings still holding it in place.This has also caused the pcl to buckle.Furthermore, they found significant damage to my knee cartilage, noting that the patient had lost nearly 20% of my cartilage compared to their healthy left knee.

• Brand Name: BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT
• Common Device Name: Resorbable implant for anterior cruciate ligament (ACL) repair
• Manufacturer (Section D): MIACH ORTHOPAEDICS; 69 milk street; suite 100; westborough MA 01851
• Manufacturer (Section G): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: gregory devenne ; 69 milk street; suite 100; westborough, MA 01851
• MDR Report Key: 23607598
• Report Number: 3020652-2025-00028
• Device Sequence Number: 21146917
• Product Code: QNI
• UDI-Device Identifier: 00860002987804
• UDI-Public: (01)00860002987804(17)281224(10)7008409
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K243578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/28/2024
• Device Catalogue Number: 1000
• Device Lot Number: 7008409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male