FDA Adverse Event Injury Summary report: N

VERTEX RECONSTRUCTION SYSTEM

MDR report key: 9179146 · Received October 11, 2019

Report

Report Number: 1030489-2019-01150
Event Type: Injury
Date Received: October 11, 2019
Date of Event: September 12, 2019
Report Date: October 11, 2019
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

OTHER: NEUROLOGICAL SYMPTOM. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958712, 510K # K042789, 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 POSTERIOR FIXATION AT C2-C7 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. POST-OPERATIVELY, THE BONE FRAGMENT AT THE LEVEL WHERE SCREW WAS INSERTED APPEARED TO HAVE BROKEN AND THAT BONE FRAGMENT IS CAUSING THE NEUROLOGICAL SYMPTOM. BONE FRAGMENT AT THE SCREW INSERTION SITE WAS NERVE COMPRESSED. IT IS UNKNOWN WHETHER THERE WAS ANY MALFUNCTION WITH THE ALLEGED SCREW OR NOT BECAUSE THERE IS NO PLAN FOR REMOVAL. THERE IS PROBABLY NO MALFUNCTION. THE OPERATION FOR REMOVING THE BONE FRAGMENT WAS PERFORMED. THE IMPLANT WAS NOT TOUCHED. IT IS UNKNOWN WHETHER THE PATIENT ACHIEVED SOLID FUSION OR NOT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
973479	VERTEX RECONSTRUCTION SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R