FDA Adverse Event Injury Summary report: N

VENTURE ANTERIOR CERVICAL PLATE SYSTEM

MDR report key: 1805096 · Received August 13, 2010

Report

Report Number: 1030489-2010-01054
Event Type: Injury
Date Received: August 13, 2010
Date of Event: June 24, 2010
Report Date: July 20, 2010
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: HWC
PMA / PMN Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT H09J3643, AND H093644. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9791323, 510K # K061274 WAS CLEARED IN THE UNITED STATES. THE MFR DATE FOR LOT H09J3643 IS 10/14/2009. THE MFR DATE FOR LOT H09J3644 IS 10/13/2009. THE X-RAYS SHOW THE ANTERIOR FIXATION PLATE AND SCREWS AT C3-C4-C5-C6. NOTED THE CONSTRUCT IS IN GOOD POSITION POST OP. SMALL PROJECTION OF C3 SCREW IS NOTED IN IMMEDIATE POST OP FILM BUT THIS IS INCONCLUSIVE. ONE MONTH POST OP FILM SHOWS C3 SCREW BACKED OUT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

Description of Event or Problem · 1

IT WAS REPORTED THAT PT UNDERWENT A CERVICAL PROCEDURE AND ANTERIOR FIXATION PLATE AND SCREWS WERE IMPLANTED AT C3-C5. ONE OF THE C3 SCREWS BACKED OUT ONE MONTH POST OP. THE REVISION SURGERY WAS PERFORMED A MONTH POST OP, THE WHOLE CONSTRUCT WAS REPLACED TO THE NEW ONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VENTURE ANTERIOR CERVICAL PLATE SYSTEM	BONE SCREW	HWC	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	IMPLANT:\| ANTERIOR CERVICAL PLATE\| EXPLANT: