MAUDE Adverse Event Report: LDR MÉDICAL AVENUE-L INSTRUMENT SET; /

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

Device not identified yet.

Event Description

Avenue l : potential vertebral fracture first cage was implanted without problem.The disc preparation of the second level was difficult, with possible fracture of the superior vertebral plate.This possible fracture was noticed by reporter on xr images when trialing.Issue can't be confirmed by reporter because the image quality was bad and orientation wasn't good to be certain of this fracture.This can't be confirmed also because patient has very soft bone and has been through many operations.At the end of the surgery, surgeon was very satisfied and there was no confirmed complication for patient.

Manufacturer Narrative

Traceability and dhr can not be reviewed as instruments used to performed the discectomy and endplates preparation are unknown.However ancillary sent for this surgery is part of a loan kit.Products have been inspected after their last use by field return inspection and did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.As reported: surgeon encountered difficulties during discectomy and endplates preparation.Patient has soft bones and has been through many operations and quality of x-rays was bad and orientation wasn't good to be certain of this fracture.Regarding information provided, root cause of probable endplate fracture is related to surgeon bone preparation and not device related.The investigation found no evidence to indicate a device issue.

• Brand Name: AVENUE-L INSTRUMENT SET
• Type of Device: /
• 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: loic richard ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3325823263
• MDR Report Key: 7012545
• MDR Text Key: 91416570
• Report Number: 3004788213-2017-00184
• Device Sequence Number: 1
• Product Code: OVD
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR94A06
• Device Lot Number: 25012012AR
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 38 YR