FDA Adverse Event Malfunction Summary report: N

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

MDR report key: 9955171 · Received April 13, 2020

Report

Report Number: 3004788213-2020-00039
Event Type: Malfunction
Date Received: April 13, 2020
Date of Event: June 11, 2019
Report Date: April 13, 2020
Manufacturer: LDR MÉDICAL
Product Code: OVE
UDI-DI: 03662663017343
PMA / PMN Number: SEE H10
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

PMA/ 510(K): 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 AND NO PHOTOS WERE PROVIDED. THEREFORE, AN EVALUATION WAS UNABLE TO BE PERFORMED, NO RESULTS ARE AVAILABLE, AND NO CONCLUSIONS CAN BE DRAWN. A REVIEW OF THE MANUFACTURING RECORDS DID NOT INDICATE ANY NONCONFORMANCES OR TEMPORARY DEVIATIONS ASSOCIATED WITH THIS LOT. ALL INSPECTED CHARACTERISTICS WERE FOUND TO BE CONFORMING, SO THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE'S LABELING WAS REVIEWED AND INCLUDES INFORMATION REGARDING PROPER DEVICE USAGE AND INSTALLATION. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT ANTERIOR PORTION OF A CAGE FRACTURED WHILE THE LOCKING PLATES WERE BEING INSTALLED. THE CAGE WAS REMOVED AND REPLACED WITH AN ALTERNATIVE CAGE TO COMPLETE THE PROCEDURE. THERE WERE NO IMMEDIATE CONSEQUENCES TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
417920	ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM	SIMILAR TO ROI-C TITANIUM-COATED IMPLANT SYSTEM	OVE	LDR MÉDICAL	NA	67295/0218-231118	03662663017343

Patients

Seq	Age	Sex	Outcome	Treatment
1