MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H10MM 27X30MM 6; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problems Break (1069); Crack (1135); Mechanical Jam (2983); Positioning Problem (3009)

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

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Implant discarded.

Event Description

Roi-a : anchoring plate jammed + cage fractured.Cage was implanted in l5-s1 disc space.Surgeon attempted to implant the first anchor but could not do it correctly due to the position of the cage (anchor penetrated the outer cortex of the anterior portion of the sacrum).Surgeon wanted to reposition the cage so tried to retrieve the plate, but it was jammed, and it caused the cage to crack off.Implants were removed and new ones were inserted.There was no injury to the patient.No broken part in the patient body.Broken implant were discarded.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 were requested to have a better understanding of this case and to provide advices to surgeon on surgical technique.

Manufacturer Narrative

Additional information received on 30 oct 2017 : it was a two level surgery (reported issue only on one level).For the level where issue occured, plates were removed and implanted again with a new cage.No images will be provided, reporter don't have information about the indication for the initial surgery.The plate hook was used to retrieve the anchoring plate.Investigation is in progress.

Event Description

Roi-a: anchoring plate jammed + cage fractured.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.B4 ; g1-2; g7 ; h2 ; h6 & h10 were updated.The review of the inspection records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.From information provided, based on the product history records, the review of the case and the recurrence of this type of event for this implant, it is assessed that the event is related to mishandling , applying excessive force upon removant of anchoring plate which caused the cage breakage.There is no evidence to indicate a device issue.

Event Description

Roi-a : anchoring plate jammed + cage fractured.

• Brand Name: ROI-A CAG MED H10MM 27X30MM 6
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 6951032
• MDR Text Key: 89365161
• Report Number: 3004788213-2017-00143
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR2522P
• Device Lot Number: M42593
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR