MAUDE Adverse Event Report: LDR MÉDICAL MC+ ANCHORING CLIP; SPINE VERTEBRAL BODY REPLACEMENT DEVICE

Model Number N/A

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the an initial report about a complaint.Product was not returned to ldr medical (still implanted).No visual and functional evaluation can be performed.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.Information requests are in progress to obtain more information about the incident.Investigation still in progress.Conclusion not yet available.

Event Description

Mc+ : difficulty at insertion.The reporter received "an" information on the 25/oct/2018 that dr (b)(6) had problems with a mc+ operation.It was a two level surgery and the surgeon had difficulties during insertion of the anchoring plates on both levels.According to the surgeon, it seemed that the anchoring plates were too large to fit correctly inside the cage.He tried to force it but the anchoring plates would not be fully inserted.So the anchoring plates stayed partially implanted in the patient's bones and the surgeon decided to leave them in this state and to close the patient.The reporter also asked about the patient's bones and the surgeon said that it was not particularly hard bones.Then no issue concerning compatibility between the cage and the corresponding anchoring plates chosen for this surgery according to the reporter.Additional information requested to the reporter.

Manufacturer Narrative

Additional information received on january 3rd 2019 : the patient is in good condition no revision planned instruments are planned to be returned to the manufacturer surgical technique were followed during surgery the surgeon is used to work with mc+ and performed other surgeries with mc+ without any trouble.Investigation still in progress.Conclusion not yet available.

Event Description

Mc+ : difficulty with anchoring plate insertion additional information received on january 3rd 2019 : the patient is in good condition no revision planned instruments are planned to be returned to the manufacturer surgical technique were followed during surgery the surgeon is used to work with mc+ and performed other surgeries with mc+ without any trouble.

Event Description

Mc+: difficulty with anchoring plate insertion.Based on the available information, it was a two level mc+ surgery and the surgeon had difficulties during insertion of the anchoring plates on both levels.The surgery was completed without "further" issue and no patient impact.A request was made to "retrieve" the "instrumentation" used during the surgery.On january, instruments were returned to the manufacturer, however, the reporter cannot identify which ones were used during this surgery.Additional request were made to have more clarification on the surgical steps followed, however the surgeon "didn't" add any update.

Manufacturer Narrative

This medwatch is submitted to send the final report.The cages and the anchoring plates remain implanted.According to the available information there was no impact on the patient for this case.The instruments potentially used during this surgery were returned, and there examination shows no evidence on a deviation that may have an impact on this event.Based on the device history review, the recurrence of this type of event for this implant range and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.The likely cause of the event is that the anchoring plate may have been in conflict with instruments during impaction.However , this hypothesis cannot be validated with the available inputs.The investigation found no evidence to indicate a device issue.The exact root cause of this event remain undetermined.If additional informations were received that add a value on this conclusion another report will be sent.Implant not returned.

• Brand Name: MC+ ANCHORING CLIP
• Type of Device: SPINE VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8105172
• MDR Text Key: 128405423
• Report Number: 3004788213-2018-00382
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MC001T
• Device Lot Number: 737694
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 44 YR