FDA Adverse Event Malfunction Summary report: N

VENUS ACP

MDR report key: 7910563 · Received September 26, 2018

Report

Report Number: 1067095-2018-00008
Event Type: Malfunction
Date Received: September 26, 2018
Date of Event: August 29, 2018
Report Date: September 6, 2018
Manufacturer: SPINAL ELEMENTS
Product Code: KWQ
UDI-DI: 00840916118815
PMA / PMN Number: K103137
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

RADIOGRAPHS WERE RECEIVED DEPICTING THE EVENT. IT IS CONFIRMED THAT THE TWO SCREWS AT C7 APPEAR TO HAVE PARTIALLY BACKED OUT OF THE PLATE. NO PRODUCT WAS RETURNED, NO PRODUCT INFORMATION WAS GIVEN, AND NO FURTHER EVALUATION OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS, OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT. THERE WAS A TWO YEAR DURATION TO FAILURE. INTERNAL FIXATION APPLIANCES ARE LOAD SHARING DEVICES THAT HOLD BONY STRUCTURES IN ALIGNMENT UNTIL HEALING OCCURS. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND, OR BREAK. THE ROOT CAUSE IN THIS EVENT CANNOT BE DETERMINED.

Description of Event or Problem · 1

REPORTEDLY THE INITIAL THREE LEVEL ACDF SURGERY (C5-C7) WAS PERFORMED IN 2016. ON (B)(6) 2018, RADIOGRAPHIC IMAGING DEPICTED TWO SCREWS AT C7 HAD BACKED OUT OF THE PLATE. REVISION SURGERY IS PLANNED BUT THE PLATE CURRENTLY REMAINS IN THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
751020	VENUS ACP	ANTERIOR CERVICAL PLATE SCREW	KWQ	SPINAL ELEMENTS	VSF4012		00840916118815

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Required Intervention