VENTURE ANTERIOR CERVICAL PLATE SYSTEM

Report

Report Number: 1030489-2019-00781
Event Type: Injury
Date Received: July 17, 2019
Date of Event: June 18, 2019
Report Date: July 17, 2019
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
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

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 9790215, 510K # K042922 AND UDI # (B)(4) WAS 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL FIXATION AT C4-C6 DUE TO OSSIFICATION OF THE ANTERIOR LONGITUDINAL LIGAMENT AT C4-C6. AFTER SUBTOTAL REMOVAL AT C5, HA SPACER (DESIGNED BY ANOTHER MANUFACTURER) WAS IMPLANTED ALONG WITH THE REPORTED PLATE. IMMEDIATELY POST-OP, THE SPACER BACKED-OUT. DUE TO SPACER EXPULSION, THE IMPLANTED SCREW LOOSENED, WHICH CAUSED A CHANGE IN IMPLANTED PLATE'S POSITION. THE PATIENT ALSO EXPERIENCED DYSPHAGIA AS A RESULT OF THIS EVENT. A RE-OPERATION HAS BEEN SCHEDULED, WHEREIN PLATE REMOVAL WILL BE PERFORMED ALONG WITH SPACER REPLACEMENT. ALSO, EXTENSION OF THE FIXATION RANGE AND RE-FIXATION WILL BE PERFORMED IN THE REVISION SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
590656	VENTURE ANTERIOR CERVICAL PLATE SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	H5500751

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention