MAUDE Adverse Event Report: LDR MÉDICAL ROI-C; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

Explanted received was damaged during removal procedure.Cage is too damaged to perform adequate analysis.Bone substitute analysed by an outside laboratory and confirms cause given by reporter: pseudarthrosis.No information about location of anchoring plates.Pseudarthrosis is a known possible side effect indicated in the ifu.No evidence to indicate a device issue.Additional information: anchoring plate: ref mc1005t, lot 626477 mfr date: 26 may 2015 - expiry date: 01 apr 2020.Bone substitute: ref mc1600, lot 0213e213 mfr date: 11 jul 2013 - expiry date: 01 jun 2018.

Event Description

Revision due to pseudarthrosis: revision to remove implant and bone substitute, to replace by an osteosynthesis system.

• Brand Name: ROI-C
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION
• 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: loïc richard ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3325823263
• MDR Report Key: 6724310
• MDR Text Key: 80402656
• Report Number: 3004788213-2017-00030
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: N/A
• Device Catalogue Number: MC1340P
• Device Lot Number: 24083
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR