ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM
Received Apr 17, 2017
Report 9610612-2017-00191 · MDR key 6497253
Device
Generic name
Mplants Cervical Stabilisatio
Manufacturer
Aesculap Implant SystemsModel number
FJ933TCatalog number
FJ933T
Product problems
- Material Disintegration
- Material Disintegration
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION. DUE TO THE FACT THAT THE PRODUCT IS STILL IN-SITU, A FULL INVESTIGATION CANNOT BE CONDUCTED. CONCLUSION AND ROOT CAUSE. BASED ON THE INFORMATION AVAILABLE WE ASSUME THAT THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL. THE FACT THE DISINTEGRATED SCREW COULD ALREADY BE SEEN ONE DAY POST-OPERATIVE, LED TO THE ASSUMPTION THAT THE SCREW ALREADY CAME LOOSE INTRA-OPERATIVELY DUE TO AN INCORRECT ASSEMBLY. CORRECTIVE ACTION. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.
Description of Event or Problem
COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT THE IMPLANT HAS DISINTEGRATED IN THE AREA OF THE SCREW (CLOSURE PINS). THE METAL PIN LIES IN THE PATIENT AND MIGRATED.