SYNPOR SMOOTH FAN PLATE 35MM/0.8MM THICK-STERILE
Received Dec 9, 2014
Report 2520274-2014-15198 · MDR key 4307361
Device
Product problems
- Migration or Expulsion of Device
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE SCAN AND IT WAS NOTED THAT THE IMPLANT SHIFTED. PATIENT REPORTED EXPERIENCING PAIN POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT IS FOR 1 OF 1 FOR COMPLAINT (B)(4).
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE PRODUCT CODE: FTM IS THE CORRECT CODE; XXX WAS ENTER AS THERE ARE SYSTEM ISSUES. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.