FDA Adverse Event
Malfunction
Summary report: N
X-RING FIXATOR
MDR report key: 23417471
·
Received October 29, 2025
Report
- Report Number
- 3007289093-2025-00012
- Event Type
- Malfunction
- Date Received
- October 29, 2025
- Date of Event
- September 15, 2025
- Report Date
- October 29, 2025
- Manufacturer
- EXTREMITY MEDICAL, LLC.
- Product Code
- KTT
- UDI-DI
- 00842078136478
- PMA / PMN Number
- K251128
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE POLYAXIAL STRUTS WERE ASSEMBLED IN A HEXAPOD CONFIGURATION. 1 OF THE 6 STRUTS WAS COMPRESSED BY 5MM WITHOUT COMPRESSING ANY OF THE OTHER STRUTS. THE BLACK COLLET SEPARATED FROM THE BLUE STRUT BODY WHEN COMPRESSING. A 2ND STRUT WAS COMPRESSED BY 5MM CAUSING THE BODY TO SEPARATE FROM THE COLLET AGAIN. ALTHOUGH THE STRUT BODY SEPARATED FROM THE COLLET ON 2 OF THE 6 STRUTS, THE STRUTS WERE STILL STABLE AND WERE ADEQUATE TO LEAVE AS PART OF THE FRAME ASSEMBLY. THERE WAS NO IMPACT TO PATIENT, AND THERE WERE NO CONCERNS REGARDING CONSTRUCT STABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212566 | X-RING FIXATOR | EXTERNAL FIXATION DEVICE | KTT | EXTREMITY MEDICAL, LLC. | 257418 | 00842078136478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Unknown |