FDA Adverse Event Injury Summary report: N

INFUSE

MDR report key: 2201078 · Received August 11, 2011

Report

Report Number: 1030489-2011-01025
Event Type: Injury
Date Received: August 11, 2011
Report Date: July 12, 2011
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NEK
PMA / PMN Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIST

Narratives

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510400, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510400, PMA # P050053 WAS CLEARED IN THE UNITED STATES. A REVIEW OF MULTIPLE CT SCANS WITH CORONAL AND SAGITTAL VIEWS SHOW LACK OF DENTITION ON THE LEFT AREA OF PREVIOUS RHBMP-2 GRAFTING. IMAGES SHOW NO SIGNS OF NEW BONE GROWTH. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH RHBMP-2/ACS AT THE MAXILLARY SINUS. 165 DAYS POST-OP, THE PATIENT RETURNED TO THE SURGEON'S OFFICE FOR A FOLLOW UP CT SCAN. PER THE SURGEON, THE CT SCAN SHOWED NO EVIDENCE OF BONE GROWTH THEREFORE THE PATIENT IS NOT SUITABLE FOR DENTAL IMPLANTATION AT THIS TIME. TREATMENT HAS NOT YET BEEN DETERMINED FOR THIS PATIENT. ANOTHER SURGERY WILL BE REQUIRED TO RE-GRAFT THE SITE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSE	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	NEK	MEDTRONIC SOFAMOR DANEK USA, INC	NA	M110905AAS

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention