HTR-PMI KRAUS LF TEMP PAR
Received Mar 1, 2013 · Event occurred Feb 14, 2013
Report 0001032347-2013-00041 · MDR key 2985038
Device
Generic name
Htr
Manufacturer
Biomet MicrofixationModel number
N/ACatalog number
PM613225
Lot number
437230
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
THE PATIENT HAD THE HTR REMOVED DUE TO AN INFECTION.
Additional Manufacturer Narrative
REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY REPORTED THAT THE COMPLAINT ITEM WAS DISCARDED DURING THE REVISION SURGERY AND THEREFORE NOT AVAILABLE FOR REVIEW BY THE MANUFACTURER. THE USER FACILITY REPORTS THAT THE REVISION WAS SUCCESSFUL AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.