MalfunctionKWQ
ABC SELF-LOCKING CERVICAL SCREW 4. 0X16MM
Received Jul 18, 2014 · Event occurred Jun 16, 2014
Report 3005673311-2014-00061 · MDR key 4030898
Device
Generic name
Implants Cervical Stabilisation
Manufacturer
Aesculap Implant SystemsModel number
FJ933TCatalog number
FJ933T
Lot number
51685473
Product problems
- Migration or Expulsion of Device
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
SIX FJ933T WERE RETURNED FOR EVALUATION; LOT NUMBERS: 51685473 (1), XXX85473 (1), UNKNOWN (4), (TOO DAMAGED TO DETERMINED). CERVICAL PLATE WAS RETURNED FOR EVALUATION AS A COMPONENT: FJ758T/AC CERVICAL PLATE 6 HOLD TA 37MM, LOT NUMBER 51095813.
Description of Event or Problem
SCREW REMOVAL CASE BECAUSE THE LOCKING MECHANISM ON THE SCREWS FLIPPED. ORIGINALLY IMPLANTED IN (B)(4).