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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORD CAGE H06 14X17MM; INTERVERTEBRAL BODY FUSION DEVICE
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LDR MÉDICAL ROI-C LORD CAGE H06 14X17MM; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Model Number N/A
Device Problems Flaked (1246); Device Markings/Labelling Problem (2911); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
The product was not returned to ldr medical yet.No visual and functional evaluation could be performed.The review of the device history records and the traceability is in progress to find if there is any non-conformances to specifications or deviations in procedures that might have contribute dto the reported event.The investigation still in progress.Conclusion not yet available.
 
Event Description
Roi-c : the label on steripack was flaking off.Distributor reports on nov.30th 2018 that : opened sterile packaging and the label on the steripack was flaking off of the packaging.Additional information on december, 05th 2018: the reporter provided some photos of the issue and the sales order so.Additional information on december, 11th 2018: the label was cracked and peeling prior to the scrubs touching it.No effect from the product label on the patient.The event happened during the case.The surgery not delayed over 30min.The reporter had replacement product.Delay of 10 min or so.The label was partially unglued, and easily flaked off when bent while peeling the sterile pack.The reporter confirm that is the inner label sticker.Additional information was required.
 
Event Description
Roi-c : the label on steripack was flaking off.Distributor reports on nov.30th 2018 that : opened sterile packaging and the label on the steripack was flaking off of the packaging.Additional information on december, 05th 2018: the reporter provided some photos of the issue and the sales order so.Additional information on december, 11th 2018: the label was cracked and peeling prior to the scrubs touching it.No effect from the product label on the patient.The event happened during the case.The surgery not delayed over 30min.The reporter had replacement product.Delay of 10 min or so.The label was partially unglued, and easily flaked off when bent while peeling the sterile pack.The reporter confirm that is the inner label sticker that was cracked.
 
Manufacturer Narrative
This medwatch is submitted to send the result of the investigation of this complaint.The product was returned on march 13rd 2019 in a condition making the analysis imposible.No visual examination could be performed.Review of the complaint history found no other similar issue for this lot or for this device range.The issue was detected before implant use , during the opening of implant pacakaging without patient impact or surgery complication.From the information provided, the product history records and the recurrence of this type of event for this product, the investigation found that the material of the holder tab used for the device could present a fragility for the gamma sterilization.Therfore , an improvement measure was initiated to change this matirial to a tyvek holder tabs , which is more resistant to the sterilization.
 
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Brand Name
ROI-C LORD CAGE H06 14X17MM
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
LDR MÉDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine 10300
FR  10300
MDR Report Key8193541
MDR Text Key131304907
Report Number3004788213-2018-00421
Device Sequence Number1
Product Code OVE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2019
Device Model NumberN/A
Device Catalogue NumberMC1432P
Device Lot Number34848
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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