FDA.reportPublic FDA data

MAUDE MDR 9888729

MDR report key
9888729
Report number
9610612-2020-00097
Event key
0
Event type
3
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS KERSTIN ROTHWEILER
Address
PO BOX 40 TUTTLINGEN, 78501 GM
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1QUINTEX SEMICONSTRAINED SCREW 4.0X18MMSPINE SURGERYAESCULAP AGKWQSC504TSC504T52550208Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

N

Patient 1

GENERAL INFORMATION: THE SCREW ARRIVED IN DECONTAMINATED CONDITION. CONSEQUENCES FOR THE PATIENT ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. INVESTIGATION: THE RECEIVED SCREW EXHIBITS NO DEFECTS, THE LOCKING RING IS IN ITS CORRECT POSITION INVESTIGATION: WE MADE A VISUAL INSPECTION OF THE COMPLAINED SCREW. EXCEPT A SLIGHT WEAR ON THE THREAD, MOST LIKELY CAUSED BY THE SCREWING IN AND OUT OF THE SCREW, WE FOUND NO ABNORMALITIES OR DEFECTS. THE LOCKING RING IS IN ITS CORRECT POSITION BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THERE ARE NO FURTHER COMPLAINTS WITH THIS LOT AT HAND CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE FOR THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE: THE POPPING OUT OF LOCKING RINGS IS NORMALLY CAUSED BY DRIVING THE SCREWDRIVER IN THE HEAD OF THE SCREW WITH A WRONG (TOO LOW) ANGLE. THE COMPLAINT SAMPLE HAS ITS LOCKING RING IN THE CORRECT POSITION, WE FOUND NO DEVIATION TO THE SPECIFICATION (MAYBE THE RING WAS PUSHED IN THE HEAD OF THE SCREW AGAIN AFTER SURGERY). ACCORDING TO SOP (B)(4) (CORRECTIVE ACTION & PREVENTIVE ACTION) A CAPA IS NOT NECESSARY.

D

Patient 1

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH QUINTEX SEMI-CONSTRAINED SCREW . IT WAS REPORTED THAT THE REPORTED TORN OUT OF THE ANCHORAGE WHEN SCREWING IN. THE MALFUNCTION OCCURRED DURING A SPINAL C7-TH1 PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO PATIENT INJURY. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER (B)(4).