MAUDE Adverse Event Report: LDR MÉDICAL ROI-A AP REVISION HOOK; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problems Break (1069); Component Missing (2306); Material Twisted/Bent (2981)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report.Products returned to ldr.Evaluation of the device is still in progress.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.More information requested, waiting for an answer.Investigation still in progress.Conclusion not yet available.

Event Description

Detected at field return on (b)(6) 2018 : the roi-a anchoring plate hook is broken (missing part of the hook) and the blade of removal cutter is bent.These instruments are used for revision procedure, so they are involved in revision procedure.Further information has been requested and no further information received yet.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.B4 ; g1-2; g4 ; g7 ; h2 ; h6 & h10 were updated.Additional information received on january 7th 2019 : missing part retrieved and not in patient body no problem occured during surgery, normal wear of the device.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, the investigation found no evidence to indicate a device malfunction but a wear from normal use of the device.Concerning the revision, no information has been provided despite the 3 follow-ups request.The breakage of the instrument was "therefore" related to normal wear from use.However, the "revision" root cause remain undetermined due to the lack of available information.

Event Description

Roi-a : revision instrument : broken hook and bent blade.Detected at field return on dec.12th 2018 : the hook is broken and the blade of removal cutter is damaged.These instruments are used for revision procedure, so they are involved in revision procedure.Additional information received on january 07th 2019 : missing part has been discarded by hospital.Piece retrieved and not in patient body.The reporter also answered that no problem has occured during the revision and both instrument are wear form normal use.No information about the reason of the surgery despite the follow-ups requests.

• Brand Name: ROI-A AP REVISION HOOK
• 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: 8211803
• MDR Text Key: 131895867
• Report Number: 3004788213-2019-00004
• 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
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR9288R
• Device Lot Number: 410304347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention