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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report.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.As indicated product is retained by hospital, therefore, no product evaluation could be performed.Additional information was requested and reply is still pending.Investigation is still in progress.Conclusion is not yet available.Product retained by hospital.
Event or Problem Description
Avenue l : broken cage.It was reported by sales rep, that during a avenue l surgery, the implant cracked and was unable to use.Another implant was opened and used with no further issue reported.Product will not be returned as retained by hospital.Waiting on additional information.
Additional 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 or Problem Description
It was reported that during surgery, the implant cracked and was unable to be used.Another implant was opened and used with no further impact on surgery or patient harm reported.

• Brand Name: LATERAL CAGE H10MM 17X40MM 6
• Common Device Name: SEE H10
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8706963
• Report Number: 3004788213-2019-00172
• Device Sequence Number: 16740834
• Product Code: MAX
• UDI-Device Identifier: 03662663008532
• UDI-Public: (01)03662663008532(17)211001(10)53884
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR6230P
• Device Lot Number: 53884
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 53 YR