CRIMPER F/TRANSV-ONNECTORS
Received Aug 15, 2012 · Event occurred Jun 27, 2012
Report 8030965-2012-00642 · MDR key 2705816
Device
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem
A DEVICE REPORT FROM (B)(6) INDICATED A HOSP IN (B)(6) REPORTED: PT WHO HAD A CERVICAL DISLOCATION BONE FRACTURE WAS BEING TREATED WITH POSTERIOR CERVICAL SPINAL FUSION USING THE SYNAPSE AND INSERTED PS TO C5-TH2. DURING THE ADDITION OF A TRANSCONNECTOR AT FINAL FIXATION THE EDGE OF THE CRIMPER BROKE AND WENT INTO THE PT. SURGEON WAS UNAWARE OF THE CRIMPER BREAKING DURING THE PROCEDURE AND IT WAS FOUND AFTER THE PROCEDURE ON POST OP X-RAYS. SURGEON RETURNED THE PT TO THE OPERATING ROOM AND REMOVED THE BROKEN PIECE OF THE CRIMPER. SURGEON NOTED HE DID NOT FEEL THE CRIMPER BREAKING.