| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GRAFTON DBM | BONE GRAFTING MATERIAL, HUMAN SOURCE | OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC) | NUN | A43110 | A43110 | OTSCT0833554035 | * | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-06-27 | 0 | 1. R |
Patient 1
PATIENT REPORTED THAT SHE HAD HAD ALLOGRAFT BONE VOID FILLER AND METAL INSTRUMENTATION IMPLANTED DURING A POSTERIOR CERVICAL FUSION, AND 6 WEEKS AFTER HER SURGERY, SHE DEVELOPED AND HAS HAD A RASH AND ?LUMP? IN THE BACK OF HER NECK DIRECTLY OVER THE INSTRUMENTATION. PATIENT STATED SHE IS FOLLOWING UP WITH A DERMATOLOGIST TO DETERMINE IF SHE IS EXPERIENCING AN ALLERGIC REACTION. PATIENT STATED SHE DID NOT DEVELOP ANY POST-OPERATIVE INFECTION.
Patient 1
THIS MEDWATCH REPORT WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. MULTIPLE DEVICES WERE IMPLANTED DURING THE REPORTED PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(6). (B)(4). REVIEW OF THE MANUFACTURING RECORDS FOR THE SUBJECT DEVICE INDICATED THAT THE PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. MEDTRONIC HAS NOT RECEIVED ANY ADDITIONAL REPORTS OF THIS NATURE INVOLVING ANY OTHER PRODUCT MANUFACTURED FROM THIS DONOR TISSUE. THE SUBJECT PRODUCT WAS PART OF THE ABOVE THERE WAS NO REPORT OF ANY POST-OPERATIVE INFECTION.