MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG IST H12MM 27X36MM 14; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Implant received without decontamination form, further investigation can not be yet performed.One probably cause of implant breakage can be likely do to hard bone patient, waiting for further information and decontamination form to determine a root cause.

Event Description

The cage was implanted / placed by the surgeon according to the surgical technique when the blades / anchoring plates were inserted, the implant got broken.The bone to be treated was extremely firm.Also the 2nd implant used could not be final anchored, since the anchoring plate did not sink into the cage; a stronger striking of the anchoring plate could have caused a renewed implant fracture.

Manufacturer Narrative

Product was received, issue is confirmed : a crack is viewable on the cage around threaded hole and there is a broken part of peek near anchoring plate slot.Review of traceability for lot 16-085693 shows 31 products were released in june 2016.7 are in ldr medical inventory, 11 are in customer inventory, 13 were invoiced without any other issue reported.The review of device history records did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event.As reported, bone was extremely firm.From information received, starter awl (instrument used to create path and ease insertion of anchoring plate) was used in size "s".Each ancillary contains support for starter awl for size s / m / l.Anchoring plate used for this surgery was a size "m" so a support for starter awl size "m" should have been used by surgeon to create a completed path and avoid the breakage of the cage due to patient hard bone.Root cause is related to a user error, investigation found no evidence to indicate a device issue.

• Brand Name: ROI-A CAG IST H12MM 27X36MM 14
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: florence chapaud ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3310648075
• MDR Report Key: 6756982
• MDR Text Key: 81500856
• Report Number: 3004788213-2017-00039
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR5282P
• Device Lot Number: 16-085693
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR