UNK
Received Jun 3, 2026 · Event occurred Jul 1, 2023
Report 1220246-2026-03192 · MDR key 25376185
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Aseptic loosening
Narrative
Description of Event or Problem
ON 10-MAY-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2023 BY ARTHROSCOPY, TITLED ¿CLAVICULAR TUNNEL WIDENING AFTER ACROMIOCLAVICULAR STABILIZATION SHOWS IMPLANT-DEPENDENT CORRELATION WITH POSTOPERATIVE LOSS OF REDUCTION¿. THE STUDY REVIEWED SIXTY-FIVE (65) PATIENTS THAT UNDERWENT ATHROSCOPICALLY-ASSISTED STABILIZATION FOR AN ACUTE (TRAUMA/SURGERY INTERVAL < 3 WEEKS 26) ROCKWOOD TYPE 3 TO 5 AC JOINT INJURY, USING AC DOG BONE / LOW-PROFILE AC BUTTON (ARTHREX). DURING THE 6-MONTH FOLLOW-UP PERIOD, FORTY (40) PATIENTS EXPERIENCED LOSS OF REDUCTION (PARTIAL OR COMPLETE). SOURCE: BELLMANN, F., ET AL. (2023). "CLAVICULAR TUNNEL WIDENING AFTER ACROMIOCLAVICULAR STABILIZATION SHOWS IMPLANT-DEPENDENT CORRELATION WITH POSTOPERATIVE LOSS OF REDUCTION." ARTHROSCOPY 39(11): 2273¿2280.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.