FDA Adverse Event Injury Summary report: N

VERTEX RECONSTRUCTION SYSTEM

MDR report key: 9980489 · Received April 21, 2020

Report

Report Number: 1030489-2020-00467
Event Type: Injury
Date Received: April 21, 2020
Report Date: April 21, 2020
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: KWP
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

PMA/510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #6950315, 510K # K052180, 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 OCCIPITO THORACIC POSTERIOR FIXATION SURGERY AT O-TH4 DUE TO CEREBRAL PALSY. POST-OP, POSTERIOR FIXATION WAS PERFORMED AT O-TH4 USING HYBRID OF VERTEX SELECT AND SOLERA5.5. AFTER THE OPERATION, AROUND C1 LEVEL, ROD BREAKAGE OCCURRED TO THE LEFT SIDE, AND ON THE RIGHT SIDE, THE SET SCREW AND THE ROD BACKED OUT. IT WAS PLANNED TO PERFORM A REVISION SURGERY (IT WAS PLANNED TO REMOVE ALL OF THE SET SCREWS AND RODS (TITANIUM ALLOY) AND TO PLACE NEW RODS (COBALT CHROME ALLOY)) ON (B)(6) BUT REVISION SURGERY HAS BEEN POSTPONED, AND THE DATE OF SURGERY HAS NOT YET BEEN DETERMINED. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
444350	VERTEX RECONSTRUCTION SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention