MAUDE Adverse Event Report: LDR MÉDICAL LATERAL CAGE H10MM 17X40MM 6; SEE H10

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to manufacturer.Examination was not performed.The review of the traceability and the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.From information provided : the surgeon wants to put a cage avenue l 17 x 40 and finally put a 17x35.No fluoroscopy control for the test of the trial implant was performed by the surgeon , which explains the wrong size chosen.The review of the case indicate that the root cause of this event is an user error.Indeed as indicated in the surgical technique: "insert the chosen trial implant in the intervertebral space using the slotted mallet; make sure it is stable (slight compression) in between the vertebral bodies.Control under fluoroscopy: lateral view: depth, antero-posterior positioning and position in rotation - frontal view: centering, lateral coverage and position in rotation." investigation found no evidence of a product issue.Root cause is user error (surgeon didn't follow instruction for trial control).Device not returned to manufacturer.

Event Description

Avenue-l : ir6230p, wrong cage size.The surgeon wants to put a cage avenue l 17 x 40 and finally put a 17x35.No fluoroscopy control for the test of the trial implant was performed by the surgeon , which explains the wrong size chosen.The implant was discarded by the hospital.No impact on patient or on surgery (no delay superior to 30 min reported).

Manufacturer Narrative

D2 (common device name): avenue l lateral lumbar cage, avenue t tlif cage system, roi-a alif cage system, roi-t implant system.The cage was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during surgery, the surgeon attempted to place an implant that was too large for the space.The initial implant was switched for a smaller size and the surgery was completed without further issues.

• Brand Name: LATERAL CAGE H10MM 17X40MM 6
• Type of Device: SEE H10
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7591902
• MDR Text Key: 110792562
• Report Number: 3004788213-2018-00205
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR6230P
• Device Lot Number: 59826
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1