MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H10MM 27X36MM 6; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Additional information received jan 31st 2018 : "implant wouldn't load correctly onto the inserter.Tech attempted to load but implant would not tighten onto inserter." other information received feb 02nd 2018 : it was a 2-level-surger :l4/5 and l5/s1.The implant was not broken attempting to implant into patient.It was broken on the back table, then there was not an in&out implant.No issues with the 2 implants cages were reported during the surgery, a multi piece inserter was used for 2 implanted cages because first inserter was deemed unusable." additional information were requested and investigation is in progress.Device not received yet by manufacturer.

Event Description

Roi-a : implant wouldn't hold on implant holder.Implant wouldn't load correctly onto the inserter.Srib tech attempted to load but implant would not tighten onto inserter.Inserter was deemed unusable and another instrument was used without further issue.

Event Description

Roi-a : implant wouldn't hold on implant holder.Product received at ldr medical on march 12th.2018, issue is confirmed.Product examination shows threaded hole of the cage is damaged, oblic hole shows no issue and no mark.That confirms cage was not implanted.As reported : implant wouldn't load correctly into the inserter.Tech attempted to load but implant would not tighten onto inserter.It was broken on the back table.First inserter was deemed unusable so multi piece inserter was used for 2 implanted cages.No further issue reported.

Manufacturer Narrative

Product received at ldr medical on march 12th.2018, issue is confirmed : threaded hole of the cage is damaged, provided lot # of product involved in the first complaint report was not correct.The information received made possible to review the device history records and the traceability of the product associated with the event.This review identified a deviation in the product threaded hole control that could affect the event.An assessment of the risk of this non-conformance was initiated.Previous cases of broken cages were not related to a device issue.In addition ,no other issue were related to this cage lot number.Implant holder involved during this surgery was identified and inspected : ref # (b)(4), lot # 4856202/34; according to inspection form of implant holder : inserter threads were stripped.Regarding information provided, probable root cause of broken cage is related to inserter threads who were stripped and damaged the threaded hole of the cage.With a damaged threaded hole, cage can not be loaded correctly onto the inserter.If additional information that add value to this investigation another report will be sent.

• Brand Name: ROI-A CAG MED H10MM 27X36MM 6
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7262729
• MDR Text Key: 99769900
• Report Number: 3004788213-2018-00033
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR5221P
• Device Lot Number: 16-103303
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 76 YR