FDA Adverse Event Injury Summary report: N

ZEPHIR ANTERIOR CERVICAL SYSTEM

MDR report key: 3360098 · Received September 20, 2013

Report

Report Number: 1030489-2013-03960
Event Type: Injury
Date Received: September 20, 2013
Date of Event: August 22, 2013
Report Date: August 22, 2013
Manufacturer: MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
Product Code: KWQ
PMA / PMN Number: SEE H10.
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4). LOCATION : HOSPITAL. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 8792813 WITH 510K # K030327 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WITH OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL) UNDERWENT A C5 CORPECTOMY WITH A CERVICAL ANTERIOR FUSION AT C4-C6. FOURTEEN DAYS POST-OP, CT FINDINGS REVEALED THAT THE RIGHT SCREW AT C4 WAS BACKING OUT OF THE PLATE. X-RAYS WERE ALSO TAKEN TO CONFIRM THE SCREW BACK OUT. THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY TO REPLACE THE SCREW 19 DAYS POST-OP. IT WAS NOTED BY THE PHYSICIAN THAT "THE SCREW WAS INSERTED A BIT UPRIGHT AND NOT APPROPRIATE ANGLE" AND IT WAS REPORTED THAT "LOCKING FUNCTIONED NORMALLY AT THE SURGERY". NO OTHER COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
474638	ZEPHIR ANTERIOR CERVICAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS	NA	H13B2417

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	PYRAMESH