Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium 2169-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00854501006005), received between Nov 10, 2019 and Oct 15, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FIVE MONTHS AFTER PROCEDURE USING REGENETEN, PATIENT WAS HAVING PAIN AND HYPER SYNOVITIS CHANGES. PLAN AT THIS TIME WAS TO GET INFECTION LABS AND SCHEDULE PATIENT FOR A SCOPE/WASH OUT.

  Patient problems: Pain

  MAUDE report 12643219 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY PROCEDURE, THE PATIENT EXPERIENCED ONGOING SHOULDER PAIN. THE EVENT WAS TREATED WITH A REVISION SURGERY IN WHICH DEBRIDEMENT AND DECOMPRESSION PROCEDURES WERE PERFORMED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12371416 ↗
• InjuryJul 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO 1 YEAR VISIT ON WITH REPEAT MRI AND COMPLAINED OF SHOULDER PAIN. UPON REVIEW OF MRI, IT WAS NOTED SHE HAS A MODERATE GRADE PARTIAL THICKNESS ROTATOR TENDON TEAR. INITIALLY, THE PATIENT DID NOT WANT TO PROCEED WITH SURGICAL INTERVENTION BUT, SHE REACHED OUT TO THE PI TO SCHEDULE SURGERY. THE PATIENT WAS TREATED WITH THERAPY AND REVISION SURGERY HOWEVER THE EVENT IS STILL ON GOING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 10262194 ↗
• InjuryNov 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A SURGERY IN WHICH A REGENETEN BIOINDUCTIVE IMPLANT WAS USED OVER A REPAIR MADE TO TREAT A MUSCULOTENDINOUS JUNCTION TEAR OF THE INFRASPINATUS, THE PATIENT HAD OBJECTIVE STIFFNESS EARLY IN THE POST OPERATIVE COURSE, STARTING AT 6 WEEKS AND WHICH PERSISTED THROUGHOUT THE POST OPERATIVE PERIOD. NO SIGNS OF SYSTEMIC INFECTION. IMAGING 8 9 MONTHS OUT SHOWED SUBACROMIAL BURSISTIS AND A TEAR IN LINE WITH TENDON FIBERS. THE PATIENT WAS TAKEN TO THE OR WHERE THE SUBACROMIAL BURSA WAS ASPIRATED, BIOPSIED (WITH FROZEN SECTION) AND CULTURED. THE SUBACROMIAL BURSA WAS DENSE WITH SIGNIFICANT SCARRING DIRECTLY OVER THE IMPLANT AS WELL AS LATERALLY. A WASHOUT WAS PERFORMED WITH VANCOMYCIN. THE BIOINDUCTIVE IMPLANT HAD INTEGRATED INTO TENDON LATERALLY BUT HAD LIFTED MEDIALLY, WHICH HE REPAIRED WITH SUTURE AND PERFORMED A SIDE TO SIDE REPAIR OF THE TENDON. THERE WAS SYNOVITIS IN THE GLENOHUMERAL JOINT, WHICH WAS LARGELY AFFECTED; THIS WAS TREATED INTRAOPERATIVELY WITH AN INTRA ARTICULAR STEROID INJECTION. THE PATIENT WAS DIAGNOSED WITH SEPTIC BURSITIS AND TREATED FOR 6 WEEKS WITH VANCOMYCIN. NOW, SEVERAL MONTHS LATER, PATIENT HAS PROGRESSED WELL AND HAS RETURNED TO PLAYI

  Patient problems: Injury

  MAUDE report 9302917 ↗