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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H16MM 30X39MM 10; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

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LDR MÉDICAL ROI-A CAG MED H16MM 30X39MM 10; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT Back to Search Results
Model Number N/A
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Information (3190)
Event Date 04/03/2017
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation can be conducted.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.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.Device not returned.
 
Event Description
Roi-a : damaged cage and plates did not deploy properly.As reported during a roi-a surgery, implant holder stripped peek cage, the implant did not stay on instrument, therefore the plates did not deploy properly.Another implant was opened to complete surgery.Instrumentation set was inspected in field return and found compliant.No other information provided.
 
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Brand Name
ROI-A CAG MED H16MM 30X39MM 10
Type of Device
INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
Manufacturer (Section D)
LDR MÉDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine 10300
FR  10300
Manufacturer (Section G)
LDR MÉDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine 10300
FR   10300
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7572457
MDR Text Key110170484
Report Number3004788213-2018-00188
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2019
Device Model NumberN/A
Device Catalogue NumberIR5336P
Device Lot Number14-019342
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/03/2017
Initial Date FDA Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
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