SYNCAGE TRIAL SPACER HANDLE STRAIGHT
Received Dec 22, 2014 · Event occurred Nov 24, 2014
Report 2520274-2014-15516 · MDR key 4349281
Device
Product problems
- Fitting Problem
- Device-Device Incompatibility
Patient
Not reported
- Sedation
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. USED (B)(4) AS A PRODUCT CODE, NO CODE FOR (B)(4) IN JDE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PUTTING THE TRIAL BY USING THE HANDLE FOR TRIAL IMPLANT, STRAIGHT. AFTER INSERTION, THE TRIAL SUDDENLY DISENGAGED AFTER CERTAIN TIMES OF IMPACTION. THE SURGEON HAD FAILED TO REENGAGE MANUALLY BECAUSE THE LOCKING OF THE TRIAL HANDLE IS AT THE TIP . HOWEVER THE LOCKING KNOB WAS BLOCKING BY MUSCLE AND RETRACTORS AS THE PROCEDURE WAS ALIF. FINALLY, THE SURGEON HAD TO REMOVE MORE PATIENT'S BONY STRUCTURE TO LOOSEN THE TRAPPED TRAIL. THE SIZER OF SYNFIX LR WAS COSMETICALLY DAMAGED AS THIS WAS CAUSED WHEN REMOVING THE BONY STRUCTURE BY BLUR. REMOVED BONY STRUCTURE , ENDPLATE OF VERTEBRA TO ENLARGE THE DISC SPACE FOR LOOSENING THE TRIAL TRAPPED. THE CASE WAS PROLONGED 90 MINUTES BECAUSE OF THIS ISSUE. THIS REPORT IS 2 OF 2 FOR (B)(4).
Additional Manufacturer Narrative
DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS ARE NOT AVAILABLE AS DEVICE IS OLDER THAN 15 YEARS, THUS SURPASSING THE STATUTE OF LIMITATIONS FOR RETENTION OF SUCH DOCUMENTS. THE FIRST VISIBLE STOCK TRANSACTION IS DATED (B)(6) 1998. THE COMPLAINT HISTORY RESEARCH FOUND THAT THERE ARE NO APPARENT QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT AS SUCH. ¿ALIF¿ REFERENCED IN INITIAL REPORT REFERS TO ANTERIOR LUMBAR INTERBODY FUSION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
PATIENT IS GOOD.