MAUDE Adverse Event Report: LDR MEDICAL ROI-A MEDIAN IMPLANT PXL : 23X26 H 14MM 6; SEE H10

Catalog Number IR2426P

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

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.The complaint is confirmed for one (1) of one (1) returned roi-a cag med h14mm 23x26mm 6 (pn: ir2426p) for the reported failure of being jammed with an anchoring plate.The complaint is confirmed for one (1) of one (1) returned roi-a anchoring plate m (ir2008t).Per dhr review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any previous actions.A complaint history search was performed and yielded no other complaints for the reported part numbers or any of its associated lots.The devices used tor treatment.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.A definitive root cause cannot be determined.Reference report 3004788213-2020-00152.

Event Description

It was reported that during the procedure there the was a mating issue between the anchoring plates and the inserter, the plate would not advance past the end of the inserter.Alternate inserter, cage and anchoring plates were used to complete the case.There were no reported patient impacts.However, device evaluation by a zimmer biomet employee found the cage and anchoring plates to be jammed together.This is report two of two for this event.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 23X26 H 14MM 6
• Type of Device: SEE H10
• Manufacturer (Section D): LDR MEDICAL; quarter europe de l'quest; 5, rue de berlin; saint-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; quartier europe de l'quest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: florence maily ; quartier europe de l'quest; 5, rue de berlin; saint-savind, na 10300 ; FR 10300 ; 33382803
• MDR Report Key: 10621376
• MDR Text Key: 209629335
• Report Number: 3012447612-2020-00579
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: IR2426P
• Device Lot Number: 19-303155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR