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

Model Number N/A

Device Problem Break (1069)

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

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Product is not decontaminated, no product evaluation is available.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.Current information is insufficient to permit a valid conclusion about the cause of this event.More information are requested.

Event Description

Roi-a : broken cage during impaction.Description of complainant: steril cage broke during patient insertion, broken implant-holder, which according to surgeon has break the cage.The broken cage, and the broken instrument parts were removed.And x-ray was done to check that everything has been removed.

Manufacturer Narrative

Fields were updated for this report.Severals attempts were made to collect more informations on this event.First product examination shows that the returned component may come from the head of a roi-a implant holder.However the inspection of the alleged returned instrument show that it contain all it pieces.Clarifications were asked to the reporter.No updates still received.Investigation still in progress.

Event Description

Roi-a : broken cage during impaction.Update on july 19th 2018.Several attempts were made to obtain more information about the event and no further information on this complaint has been provided.An initial examination of the returned parts shows that they can come from the head of a roi-a cage holder.However the returned, instrument has no missing parts.Clarifications were requested from the reporter.Investigation still in progress.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.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.Based on the product history records, the review of the case and the recurrence of this type of event for this implant, the root cause of the event cannot be determined.Requests for additional information did not receive a response.It's possible that the surgeon performed a poor positioning, which combined with a possible condition of hard bones of the patient, caused the breaking of the cage.However, for the lack of information received from the reporter this hypothesis could not be validated.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: undetermined.If additional informations were received that allow to drawn a conclusion for this case , 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: 7410690
• MDR Text Key: 104810014
• Report Number: 3004788213-2018-00103
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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: 510248310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1