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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL ROI-C SHORT ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM
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LDR MÉDICAL ROI-C SHORT ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM Back to Search Results
Catalog Number MC1005T
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
It was reported that during the surgery, the anchor plate became deformed while the surgeon was tamping it into place.Another device was used to successfully complete the case without any impact on the patient.
 
Event Description
It was reported that during the surgery, the anchor plate became deformed while the surgeon was tamping it into place.Another device was used to successfully complete the case without any impact on the patient.
 
Manufacturer Narrative
Corrected information in d4: lot number, summary information in h10.This follow-up report is being submitted to relay initially corrected information.Summary: the complaint is confirmed for one (1) of one (1) returned roi-c plate (pn mc1005t) for the failure of deformation.Medical records were not provided for review.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of one (1) returned roi-c plate (pn mc1005t) for the failure of disassembly causing mating issues.Medical records were not provided for review.Device evaluation: visual inspection of the device using provided photos shows that the base of the returned item is deformed and one of the arms is bent inwards.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
Event Description
It was reported that during the surgery, the anchor plate became deformed while the surgeon was tamping it into place.Another device was used to successfully complete the case without any impact on the patient.
 
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Brand Name
ROI-C SHORT ANCHORING PLATE
Type of Device
ROI-C TITANIUM-COATED IMPLANT SYSTEM
Manufacturer (Section D)
LDR MÉDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine, na 10300
FR  10300
MDR Report Key11023899
MDR Text Key222961612
Report Number3004788213-2020-00227
Device Sequence Number1
Product Code OVE
UDI-Device Identifier03662663016971
UDI-Public(01)03662663016971(17)210401(10)664179
Combination Product (y/n)N
PMA/PMN Number
K151934
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2021
Device Catalogue NumberMC1005T
Device Lot Number664179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight73
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