SYNMESH 12MM DIA 88MM HEIGHT (TI)
Received Apr 9, 2010
Report 3003506883-2010-00019 · MDR key 1657996
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Therapeutic Effects, Unexpected
Narrative
Additional Manufacturer Narrative
INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. EXPIRATION DATE AND MANUFACTURE DATE CAN NOT BE DETERMINED WITHOUT A LOT NUMBER. THE COMPLAINT HANDLING UNIT (CHU) RECEIVED INFORMATION FROM THE SALES CONSULTANT ON APRIL 2, 2010 STATING THE INCIDENT OCCURRED ON (B) (6), 2010. THE CHU IS SUBSEQUENTLY SUBMITTING THIS 30 DAY NOTIFICATION ON THE INFORMATION RECEIVED ON APRIL 2, 2010. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem
A PATIENT EXPERIENCED HETEROTOPIC POSTERIOR BONE GROWTH FOLLOWING CERVICAL CORPECTOMY WITH SYNMESH. REPORTEDLY, THE SURGEON HAS BEEN FILLING THE CAGES WITH CRUSHED CANCELLOUS BONE THAT HAS BEEN SOAKED IN CONCENTRATED BONE MARROW ASPIRATE. THE DEVICE WAS EXPLANTED. THIS IS THE FIRST OF TWO REPORTS FOR THE SAME EVENT.