UNK
Received Oct 3, 2025 · Event occurred Sep 24, 2025
Report 1220246-2025-04404 · MDR key 23213752
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED¿WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT¿ARTHREX HAS DETERMINED THAT THE MOST LIKELY CAUSE IS ATTRIBUTED TO A PATIENT-SPECIFIC RESPONSE. THIS ASSESSMENT IS CONSISTENT WITH DFU-0147-EO, REVISION 4, SECTION D (ADVERSE EFFECTS), WHICH NOTES THAT: FOREIGN BODY REACTIONS HAVE BEEN REPORTED. ALLERGIC-LIKE REACTIONS TO PLA MATERIALS (INCLUDING PLLA [POLY-L-LACTIC ACID] AND PLDLA [POLY-L-D-LACTIC ACID]) HAVE BEEN REPORTED AND, IN SOME CASES, HAVE NECESSITATED IMPLANT REMOVAL. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. SILICONE SENSITIVITY, THOUGH VERY RARE, HAS ALSO BEEN REPORTED.
Description of Event or Problem
ON (B)(6) 2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT A PATIENT IS EXPERIENCING ALLERGIC CONTACT DERMATITIS POST-SURGERY. THE PATIENT WAS IMPLANTED WITH AN ARTHREX SYNDESMOSIS TIGHTROPE XP. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.