MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG IST H14MM 30X39MM 14; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

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 on device location.

Event Description

Roi-a : broken cage when impacting anchor.Reporter spoke with the surgeon.He said that the cage broke when inserting anchor because of sclerotic bones.Surgeon had refused to use starter awl.He then changed the cage and inserted a new cage without problem.No impact on patient.Attempts have been made and no further information has been provided yet.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.Several attempts have been made to obtain further information, no other information received.According to the provided description , starter awl was not used.Starter awl is provided to assist with insertion of the anchor plates in hard bone.According to provided elements and investigation results, issue is not device related.Probable root cause of device breakage is related to a failure to follow surgical technique : bone was sclerotic and surgeon refused to use starter awl.

Event Description

Several attempts have been made to obtain further information, no other information received.

• Brand Name: ROI-A CAG IST H14MM 30X39MM 14
• 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
• 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.; 5, rue de berlin; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7243454
• MDR Text Key: 99080455
• Report Number: 3004788213-2018-00022
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR5384P
• Device Lot Number: 16-123349
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2016
• 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