MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H12MM 23X26MM 6; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problems Device Expiration Issue (1216); Expiration Date Error (2528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

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.Device remains implanted.

Event Description

Roi-a : expired product implanted.Information received by ldr spine customer department that an implant with expired date was used and implanted.Customer has not communicated on this event.For (b)(6), ldr (b)(4), it is to note that for recovering the implant that come closed to expiration date, it is the responsibility of ldr spine field inventory management as well as ldr spine sales support to get the concerns implants back.From customers.For that case, requests have been done but the related agency claimed that they were unable to locate the lot # in question.In (b)(6) 2017, the agency provided a form stating they could not locate the lot items in question.Implant was eventually implanted on (b)(6) 2018.Expiration date is indicated on product (external and internal labels) and warnings are in mobi-c p&f us ifu.The hospital has been notified of this event as well as the physician.The patient is doing fine and there isn¿t any other expired products at the hospital.Additional information requested.Waiting for an answer.

Manufacturer Narrative

No additional information was received, follow-up medwatch was submitted to send the result of the investigation & the root cause in order to close the complaint.Based on the product history records, the review of the case, the recurrence of this type of event for this implant and on the fact that the product couldn't be evaluated, the root cause of the event is a user error.The investigation found no evidence to indicate a device issue.The manufacturer requested the product to be returned before the expiration date, ifu mentionned that it is necessry to check the expiration date before to use and the expiration date was written on the labeling.Root cause: user error.

Event Description

Roi-a : expired product implanted.

• Brand Name: ROI-A CAG MED H12MM 23X26MM 6
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7291578
• MDR Text Key: 100763811
• Report Number: 3004788213-2018-00044
• Device Sequence Number: 1
• Product Code: OVD
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR2424P
• Device Lot Number: 12-291612
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR