MAUDE Adverse Event Report: LDR MÉDICAL ROI-A WIDE IMPLANT PXL : 27X36 H 14MM 6; SEE H10

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

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

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the an initial report about a complaint opened on the (b)(6).Product related to this case was not returned yet to the manufacturer for examination.The review of the device history records 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 and waiting for the product to return so it can be sent to the supplier for investigation.Investigation still in progress.

Event Description

Roi-a : sterile container was found unattached.According to the reporter, a median roi-a implant box was opened in a case.The cover for the sterile container was found unattached to plastic container.Decision was taken to open another implant.In addition it was reported that the external the heat-shrinkable film over the box was intact no impact on patient or on surgery.No surgery delay reported.The product and container will be returned for examination.Investigation still in progress.

Manufacturer Narrative

D2:type of the device: common device name: avenue l lateral lumbar cage, avenue t tlif cage system, roi-a alif cage system, roi-t implant system additional info in a5, d4 (udi number), e1 (middle name, address ¿ line 1, address ¿ line 2, city), g5 (pma/510k) and h6 (patient code, device code, method code, results code).The product was not returned, so a full evaluation could not be performed.However, with the photographs provided, the complaint is confirmed for the reported failure mode of sterile packaging issue.Per the information available in the complaint file and hhed-2018-00939, it is believed that at some point, this package was opened, then returned to the zimmer biomet distribution site where the shrink wrap was replaced without confirming the contents in the box remained in a sterile condition.However, this cannot be explicitly confirmed, so the cause cannot be determined.The device was likely conforming to specifications when it initially left zimmer biomet's control.No actions are recommended per (b)(4).

Event Description

It was reported that during the procedure the sterile packaging of the roi-a implant was found damaged.An alternate implant was opened and used to complete the case.There were no reports of patient harm.

• Brand Name: ROI-A WIDE IMPLANT PXL : 27X36 H 14MM 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: 7933085
• MDR Text Key: 123806571
• Report Number: 3004788213-2018-00324
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR5225P
• Device Lot Number: 91013000R5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1