MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT HOLDER; INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM

Model Number N/A

Device Problems Failure to Disconnect (2541); Device Handling Problem (3265)

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

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report of this complaint.Additional information was requested to better understand the event.So far, the lot of the concerned instrument was not communicated by the reporter.Therefore , it's not possible to perform the review of the device history records.Investigation still in progress.

Event Description

Interbridge : cannot deploy locking plates.It was reported that a surgeon that is very familiar with interbridge perform a surgery on (b)(6) 2019.The implant was loaded onto the inserter correctly.However the inserter was not deploying the locking plates.When they tried to take it off it wouldn't release from the inserter.Time had gone by and the surgeon asked to have the second inserter which was ready for another case to be opened and a new implant placed.When surgeon put the implant on the second inserter everything was loaded fine.Surgery was therefore completed with another instrument without further complication.The first inserter just didn't seem to be working properly, the surgeon felt that the blue button wasn't quite right but and the plates where not deploying intraoperatively.Therefore , he asked for the second inserter.He reloaded it with the same size of implant and it was fine.It was a delay between 15 and 20 minutes.Additional information was received on april 24th: no issues with the patient as it was implanted successfully with a second implant.No pictures are available.Additional information was requested.Investigation still in progress.

Manufacturer Narrative

The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.The lot number is unknown; therefore the device history records are unable to be reviewed.

Event Description

It was reported that during surgery, the interbridge implant was loaded onto the inserter correctly, however the inserter was not deploying the locking plates.When an attempt was made to release the implant, it remained jammed on the inserter.A second inserter with the inner rod from the first inserter was used in its place and the surgery was completed without further issue.No patient harm was reported.

• Brand Name: IMPLANT HOLDER
• Type of Device: INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8577592
• MDR Text Key: 143960759
• Report Number: 3004788213-2019-00140
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• PMA/PMN Number: K133363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: IB9028R
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1