FDA Adverse Event Malfunction Summary report: N

CENTERPIECE CONNECT PLATE FIXATION SYSTEM

MDR report key: 12119621 · Received July 6, 2021

Report

Report Number: 1030489-2021-00889
Event Type: Malfunction
Date Received: July 6, 2021
Date of Event: June 15, 2021
Report Date: July 6, 2021
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NQW
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465, UDI# (B)(4) AND 510K# K050082 IS APPROVED FOR SALE IN US. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE CANNOT DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SCREW AND PLATE USING LAMINOPLASTY KUROKAWA METHOD OF C4-6 WAS PERFORMED FOR CERVICAL MYELOPATHY. IT WAS REPORTED THAT THE CP CONNECT BONE SCREW 2.0MMX7MM INSERTED IN THE RIGHT VERTEBRAL ARCH FROM THE CP CONNECT GULL-WING PL 10X8 PLACED IN C5 BACKED OUT. ON JUNE 14, THE DOCTOR CONFIRMED BACK-OUT AT OUTPATIENT CLINIC. CURRENTLY, CP CONNECT BONE SCREW 2.0MMX7MM WAS ABERRANT IN THE DORSAL MUSCLE, BUT THE PATIENT WAS NOT SYMPTOMATIC AND THE PLATE DID NOT BACK OUT, SO THE PATIENT WAS UNDER FOLLOW-UP. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1017310	CENTERPIECE CONNECT PLATE FIXATION SYSTEM	ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL	NQW	MEDTRONIC SOFAMOR DANEK USA, INC	G8530207	W745291

Patients

Seq	Age	Sex	Outcome	Treatment
1