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

Model Number N/A

Device Problems Positioning Failure (1158); Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

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

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Instrument was not returned to the manufacturer.It was inspected by ldr spine and found non compliant.According to the inspection the implant inserter threads were stripped.The review of the device history records and the traceability found a visual deviation that has no impact and no link with this event.The deviation was identified at the receipt control of the product from the supplier and has been resolved before instrument liberation.The alleged cage involved in the event was received by the manufacturer and a visual examination was done.Issue is confirmed : threaded hole of the cage is damaged, ( this part is treated in another report).Regarding information provided, probable root cause of broken cage is related to inserter threads who were stripped and damaged the threaded hole of the cage.With a damaged threaded hole, cage can not be loaded correctly onto the inserter.If additional information that add value to this investigation another report will be sent.

Event Description

Roi-a : damaged instrument.Implant wouldn't load correctly onto the inserter.Srib tech attempted to load but implant would not tighten onto inserter.Inserter was deemed unusable and another instrument was used without further issue.

• 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
• 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: 7482370
• MDR Text Key: 107189921
• Report Number: 3004788213-2018-00105
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• 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: 4856202
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 76 YR