MAUDE Adverse Event Report: LDR MÉDICAL AV L ANCHORING PLATE IMPACTOR; INTERVERTEBRAL BODY FUSION DEVICE

Model Number N/A

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the an initial report for this complaint except for the anchoring plate : 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.Information requests are in progress to obtain more information about the incident investigations ongoing conclusion not yet available.

Event Description

Avenue l : jammed implant and instrument.Detected at field return on (b)(6) 2018 : impact on head of instrument and anchoring plate broken and jammed in (ir90019r), handle jammed on implant-holder (ig002r), impactor jammed on implant-holder (ir90021r).

Event Description

Avenue l : jammed inserter and scratch.It was detected at field return on november 20th 2018 impact on head of instrument and anchoring plate jammed in (ir90019r-1), handle jammed on implant-holder (ig002r-avl) and impactor jammed (ir90021r).Additional information received on february 25th 2019, according to the reporter: the date of surgery was the date of sterilization written on the decontamination form, which was on (b)(6) 2018.No impact on patient was reported.No pre-, per- and post-op x-ray images are available.The reporter does not know where the missing piece of the broken anchoring plate jammed in the cage holder is.The reporter does not know whether or not a conflict with a posterior montage occurred during the surgery.The sales order of the surgery was received on march 1st 2019.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint following the additional information and product received.B3, b4, b5, d4, g1-2, g4, g7, h2 and h6 were updated.The product was received on november 19th 2018 with the decontamination form correctly completed and signed.A visual examination confirmed the reported event: the avenue l snap-on handle and avenue l anchoring plate impactor are jammed in the avenue l cage holder.The avenue l anchoring plate s is jammed in the avenue l cage holder.Moreover, there is a missing piece of the avenue l anchoring plate s.Impacts on head of the avenue l anchoring plate impactor can be observed.Product evaluation was performed by the project manager, whose result was received on february 12th 2019.Conflict marks can be observed on the anchoring plate, therefore it could be hypothesized that there was a conflict between the second anchoring plate and a posterior montage or with the first anchoring plate, meaning that the sterile starter awl was not used.The review of the device history records and the traceability of the avenue l cage holder, anchoring plate, handle and anchoring plate impactor did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Several attempts were made to the reporter to collect additional information on this event, especially concerning the patient's indications or the use of the sterile starter awl.Yet, no answer was received.From the information provided based on the zper, the product history records, the review of the case with the project manager, the recurrence of this type of event for this product and after having performed the product evaluation, the root cause of the event cannot be determined.Indeed, based on the product evaluation, it could be hypothesized that there was a conflict between the second anchoring plate and a posterior montage or with the first anchoring plate, meaning that the sterile starter awl was not used.Yet, crucial information, such as the patient's indications or the use of the sterile starter awl, was not provided.The investigation found no evidence of a device issue.The root cause of the reported event remains unknown with the most likely hypothesis of user error.If additional information is received that allows to draw a conclusion, this case will be reopened and the root cause of the complaint will be reevaluated.

• Brand Name: AV L ANCHORING PLATE IMPACTOR
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8188793
• MDR Text Key: 131133116
• Report Number: 3004788213-2018-00429
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: IR90021R
• Device Lot Number: 410317619/05
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1