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	Use of Device Problem (1670)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient stated: "it's important to inform (b)(6) and miach that i had significant pain following the surgery.The surgeon decided to include a chondroplasty and meniscus surgery while repairing my acl.After surgery, i have had constant pain and it's still bothering me today.I was unable to walk up and down stairs without significant pain for over a year and a half." and "i also have a bump that appeared immediately after surgery on my right knee that looks like osgood schlatter disease.The bump was not present before surgery.I asked the surgeon about the bump and he said it was from swelling.It's still present on my knee and protrudes even more since the swelling has subsided.My right knee continues popping, cracking and catching.".
Additional Manufacturer Narrative
Still under investigation.Will submit a follow up mdr.

• 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 01581
• Manufacturer (Section G): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: gregory devenne ; 69 milk street; suite 100; westborough, MA 01581
• MDR Report Key: 23782779
• Report Number: 3020652-2025-00030
• Device Sequence Number: 12035257
• Product Code: QNI
• UDI-Device Identifier: 00860002987804
• UDI-Public: 0100860002987804
• 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): 11/12/2025

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: 06/28/2025
• Device Catalogue Number: 1000
• Device Lot Number: 7009195
• 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: 12/11/2025
• 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: 63 YR
• Patient Sex: Female