MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H14MM 27X36MM 14; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

The product wasn't received by the manufacturer.No examination could 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.No information was provided about the anchoring plate associated to this issue.Which prevent from reviewing the device history records and traceability.However, the device history records and traceability of the invoiced anchoring plate was reviewed and no deviation was found.Unfortunately, no confirmation from the reporter was received, that the same anchoring plate was reused and invoiced.The investigation found no evidence to indicate a device issue.But investigation determined probable root cause is related to hard bone patient or user error but regarding lack of information this root cause can not be confirmed.Based on information available and on the investigation, the exact root cause of this issue can not be determined but we continue to track and trend this type of issue.

Event Description

Roi-a : difficulty while inserting anchoring plate.As reported : surgeon was unable to deploy roi-a anchoring plate through implant.Another device (cage) was used (same size).No other issue reported.Sales rep.Reported "i did not recall quality of bone, but i know we did not use the awl." no other information provided.

• Brand Name: ROI-A CAG MED H14MM 27X36MM 14
• 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: 7797378
• MDR Text Key: 117601116
• Report Number: 3004788213-2018-00278
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR5243P
• Device Lot Number: 16-103305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 63 YR