MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT HOLDER; ROI-A ALIF CAGE SYSTEM

Model Number N/A

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided, the review of the device history records and traceability cannot be performed.According to the reporter the spring is not confirmed to belong to the alleged instrument.Additional informations requested.Investigation still in progress.Conclusion is not yet available.

Event Description

Roi-a: broken implant-holder, spring fell in patient.From information provided, during a routine roi-a procedure, surgeon found a small spring inside the patient before he closed.He was able to retrieve this spring and no harm was done to the patient.No impact on surgery or delay more then 30 min.Instruments still not exanimated to confirm that the spring came from the inserter.Additional information was requested about surgical steps and about instrumentation.

Manufacturer Narrative

Additional information received on oct.09th 2018 : defective product was received with decontamination form.Deep examination of the product will be performed.The review of the inspection records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Investigation still in progress.

Event Description

Roi-a : broken implant-holder, spring fell in patient from information provided, during a routine roi-a procedure, surgeon found a small spring inside the patient before he closed.He was able to retrieve this spring and no harm was done to the patient.The patient is fine.Surgeon used the inserter.Surgeon didn't use the adjustable stop.Delay 5min.No preop films available.Instrument examination confirms that the spring came from the inserter.

Manufacturer Narrative

The returned device was evaluated; however, the decontamination form was not completed correctly.As such, a complete evaluation could not be performed; however, visual inspection of the device confirmed that the spring is detached from the rest of the device, which can only occur if the spring plunger weld has fractured.A review of the dhr did not find any issues which would have contributed to this event.As a complete evaluation and analysis could not be performed, a cause cannot be determined.

Event Description

It was reported that the surgeon found a spring from the implant holder inside of the patient prior to closing the wound.All loose parts were retrieved from the patient.There was no patient or surgical impact reported.

• Brand Name: ROI-A MEDIAN IMPLANT HOLDER
• Type of Device: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7831716
• MDR Text Key: 118724012
• Report Number: 3004788213-2018-00257
• 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: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• 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: IR9280R
• Device Lot Number: 310281502
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1