FDA Adverse Event
Injury
Summary report: N
ARTHREX MINI BIO-SUTURE TAK SUTURE ANCHOR
MDR report key: 17531190
·
Received August 12, 2023
Report
- Report Number
- MW5138105
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- March 16, 2015
- Manufacturer
- ARTHREX
- Product Code
- MAI
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, "LUNATE FRACTURES IN THE FACE OF A PERILUNATE INJURY AND AN UNCOMMON AND EASILY MISSED INJURY PATTERN." (2012) BRISENO, M., AND YAO, J., JOURNAL OF HAND SURGERY (2012) 37 A: 63-67) IT WAS REPORTED THAT THE PATIENT IN THIS CASE REPORT HAD A SECOND SURGERY TO REMOVE THE HARDWARE. HE EXPERIENCED CHONDROMALACIA ON THE HEAD OF THE CAPITATE AND POSTOPERATIVE PAIN RANGING FROM TWO TO FIVE ON A SCALE OF ZERO TO TEN AT ELEVEN WEEKS POST OPERATIVELY. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1355357 | ARTHREX MINI BIO-SUTURE TAK SUTURE ANCHOR | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | MAI | ARTHREX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |