FDA Adverse Event Malfunction Summary report: N

ACDF MECTA-C SA - PLATE FLUSH LAG H6

MDR report key: 15370482 · Received September 7, 2022

Report

Report Number: 3005180920-2022-00669
Event Type: Malfunction
Date Received: September 7, 2022
Date of Event: August 8, 2022
Report Date: November 28, 2022
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: OVE
UDI-DI: 07630040725866
PMA / PMN Number: K192906
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 08 AUGUST 2022: LOT 1922140: (B)(4). EXPIRATION DATE: 2025-01-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). THE APPLICATION SHAFT ACT AS A TORQUE LIMITER AND SHOULD BREAK OFF AS SOON AS THE FINAL TIGHTENING TORQUE IS REACHED. THE SURGEON HAS REACTED CORRECT, THE BEST WOULD HAVE BEEN TO EITHER TRY TO REMOVE THE REMAINING PIECE WITH A FORCEPS AND TO USE A NEW ANTI BACK-OUT PLATE OR TO REPLACE THE IMPLANT. THE SURGEON SHOULD DEFINITELY CAREFUL MONITOR THE PATIENT AND KEEP AN EYE ON SCREW MIGRATION, SCREW BACK-OUT CAN HAPPEN BUT DON'T HAVE TO. HOWEVER, THE COMPLICATION CAN BE SEVER IF IT HAPPENS. IT SEEMS THAT HE ACCEPTED THE POTENTIAL RISK SINCE HE WAS NOT WILLING TO REPLACE THE DEVICE/LOCKING SCREW.

Additional Manufacturer Narrative · 0

ON 7 NOVEMBER 2022, THE BRANCH CONFIRMED THAT THE DEVICE OF THIS COMPLAINT IS NOT AVAILABLE.

Description of Event or Problem · 0

THE ACDF ANTI-BACK OUT BROKE DURING SURGERY WHILE THE SURGEON TRIED TO TIGHTEN IT A LITTLE BIT MORE WITH FORCEPS. THE SURGERY WAS COMPLETED LEAVING THE PART OF THE BROKEN SCREW STUCK IN THE PLATE SO WITHOUT LOCKING CUP ON THE CONSTRUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2182878	ACDF MECTA-C SA - PLATE FLUSH LAG H6	SPINE PLATE FLUSH LAG	OVE	MEDACTA INTERNATIONAL SA	03.18.216	1922140	07630040725866

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR	Female	Other