ORTHOSORB LS 1.3MM 3 PIN KIT
Received Dec 8, 2015
Report 0001825034-2015-04912 · MDR key 5273572
Device
Generic name
Pin, Fixation
Manufacturer
Biomet TraumaModel number
N/ACatalog number
110010742
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, ¿BENDING, FRACTURE, LOOSENING, RUBBING AND MIGRATION OF THE DEVICES CAN OCCUR AS A RESULT OF EXCESSIVE ACTIVITY, TRAUMA OR LOAD BEARING.¿
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO FRACTURING PINS; HOWEVER, NO REVISION HAS BEEN REPORTED AT THIS TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED.