MAUDE Adverse Event Report: LDR MÉDICAL ROI-A IMPLANT HOLDER; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problem Disconnection (1171)

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

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Product will be returned to ldr medical for investigation.Associated devices : anchoring plate m, ref : ir2008t lot 708699; device mfr date : 28 aug 2017 _ exp date : 01 jul 2022, roi-a oblique implant h10 mm 23×26 mm 10°, ref : ir4131p lot 84603000r238; device mfr date : 01 jul 2015 _ exp date : 01 may 2020.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Additional information was requested to surgeon and are still pending.Waiting on product return.

Event Description

Roi-a : instrument issue while impacting during a roi-a surgery, surgeon had an issue with roi-a implant holder.It was a classical spondylolisthesis with a cage height 10'.When impacting the second anchoring plate, which perfectly penetrated the vertebral plate, system disconnected.Surgeon managed to impact anchoring plate almost completely.It hasn't been impacted entirely.It was an anchoring plate size m with a 10' height cage.Cage was not moving.He preferred not to break it and left it in place.Surgeon think issue is due to repeated use of this roi-a implant holder ancillary is isolated and returned to ldr.No adverse event for patient.He will have no special follow-up.Delay inferior to 30 min.

Manufacturer Narrative

This medwatch is submitted following the first conclusion of the preliminary instrument examination by the manufacturer.Device first visual examination shows no problem detected and found product compliant.Other inspection will be performed, so the investigation still in progress.Several attempts was made to collect more information on the event context and the steps followed during the surgery.No additional information are yet received.Conclusion is not yet available.

Event Description

Roi-a : instrument issue while impacting.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Product received at ldr medical on march 05th.2018 : visual, functional & dimensional examination was done by research department and quality control department.The examination shows no particular issue.For the instrument, and the associated devices ( cage and anchor) , the review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.From information provided, the cause of the issue cannot be determined.Based on the product history records, the examination of the returned instrument and the recurrence of this type of event, the investigation found no evidence to indicate device issue.The cause for the device issue is unknown.Requests for additional information did not receive a response.The investigation found no evidence to indicate a device issue.Root cause cannot be determined.If additional information were received that may have add a value on this investigation or help to drawn a conclusion another report will be sent.

• Brand Name: ROI-A IMPLANT HOLDER
• 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: 7360886
• MDR Text Key: 103137831
• Report Number: 3004788213-2018-00073
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR9280R
• Device Lot Number: 410158506/01
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1