FDA Adverse Event Malfunction Summary report: N

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

MDR report key: 10376330 · Received August 6, 2020

Report

Report Number: 3004788213-2020-00094
Event Type: Malfunction
Date Received: August 6, 2020
Date of Event: February 16, 2018
Report Date: August 6, 2020
Manufacturer: LDR MEDICAL
Product Code: OVE
UDI-DI: 03662663017299
PMA / PMN Number: SEE H10
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PMA/510(K) NUMBER: SIMILAR TO K151934. THIS DEVICE IS NOT CLEARED FOR USE WITHIN THE US. HOWEVER, IT IS SIMILAR TO CATALOG NUMBER MC1332P. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, MRI AND X-RAY IMAGES WERE PROVIDED. THE MRI IMAGE APPEARS TO SHOW THE PATIENTS CONDITION BEFORE THE SURGERY. THE X-RAY IMAGE SHOWS 2 IMPLANTS INSTALLED SUCCESSFULLY, SO THIS APPEARS TO BE AN IMAGE TAKEN AT THE END OF THE SURGERY AFTER THE BROKEN IMPLANT WAS REMOVED. NEITHER IMAGE SEEMS TO PROVIDE EVIDENCE OF THIS ISSUE. A REVIEW OF THE DHR DID NOT FIND ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. REFERENCE REPORT 3004788213-2018-00055.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE PROCEDURE THE ANCHORING PLATE WAS DIFFICULT TO INSERT INTO C5 VERTEBRAE AND WAS NOT ABLE TO BE FULLY INSERTED. THE SURGEON DECIDED TO REMOVE THE CONSTRUCT AND NOTICED THE CAGE WAS BROKEN WHEN THE IMPLANT HOLDER WAS REMOVED. THE CAGE AND ANCHORING PLATES WERE REMOVED AND REPLACED WITH ALTERNATES TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
836135	ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM	SIMILAR TO ROI-C TITANIUM-COATED IMPLANT SYSTEM	OVE	LDR MEDICAL	NA	58325/0217-100717	03662663017299

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR