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

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2008

Event Type  Injury  

Manufacturer Narrative

Product was not returned to ldr medical as remained implanted.Without a product return, no product evaluation can be conducted.The review 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.Event is resolved without sequelae at an unknown date.Fusion was acquired at 10 years post-op.No patient impact or complication was notified.X-rays provided and surgery report show there is a spondylosis and a isthmic lysis on this segment.No other information provided on the event or on the patient initial condition.Regarding information provided, root cause is probably related to hard bone but information are insufficient to permit a valid conclusion, so root cause of this event remain unknown.The investigation found no evidence to indicate a device issue.If additional information were obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Product not returned, remains implanted.

Event Description

Roi-a: anchoring plates difficulty to implant.During roi-a surgery, surgeon had difficulties to deploy / insert anchoring plate into the cage.Surgery was delayed from 200 minutes (3h20).Surgery was completed without further complication.No impact on patient.On post surgery a monitoring of the patient was applied devices still implanted.

• Brand Name: ROI-A ANCHORING PLATE
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7836389
• MDR Text Key: 118868880
• Report Number: 3004788213-2018-00141
• 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: company representative,study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2013
• Device Model Number: N/A
• Device Catalogue Number: IR2001T
• Device Lot Number: 426433
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 41 YR