LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL
Report
- Report Number
- 2939274-2021-07260
- Event Type
- Malfunction
- Date Received
- December 29, 2021
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- LXT
- UDI-DI
- 10886982199966
- PMA / PMN Number
- K122455
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL PROCODE: KTT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITIONAL PROCODE: KTT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LARGE EX-FIX 11MM CARBON FIBER ROD WAS CHIPPING AND CRACKING AND UNABLE TO STERILIZE OR ASSEMBLE. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL. THIS IS REPORT 1 OF 3 FOR (B)(4).
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LARGE EX-FIX 11MM CARBON FIBER ROD WAS CHIPPING AND CRACKING AND UNABLE TO STERILIZE OR ASSEMBLE. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL. THIS IS REPORT 1 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2011253 | LARGE EX-FIX 11MM CRBN FBR ROD 600MM / MR-CONDITIONAL | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | LXT | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 394.91 | 10886982199966 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | LG EXFIX 11 CRBN FBR ROD 650 / MR-COND| LG EXFIX 11 CRBN FBR ROD 650 / MR-COND |