END RING 12MM DIA/2.5 DEG (TI)
Received Apr 9, 2010
Report 3003506883-2010-00020 · MDR key 1657376
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
A PT 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 SECOND OF TWO REPORTS FOR THE SAME EVENT.
Additional Manufacturer Narrative
ADDITIONAL INFO HAS BEEN REQUESTED. EXPIRATION DATE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. THE COMPLAINT HANDLING UNIT (CHU) RECEIVED INFO FROM THE SALES CONSULTANT ON 04/02/2010 STATING THE INCIDENT OCCURRED ON (B) (6) 2010. THE CHU IS SUBSEQUENTLY SUBMITTING THIS 30-DAY NOTIFICATION ON THE INFO RECEIVED ON 04/02/2010. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.