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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; OC PLATE
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ULRICH GMBH & CO. KG NEON3; OC PLATE Back to Search Results
Model Number CS 3913-08
Medical Device Problem Codes Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/13/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer).Exemption # e2014011.
 
Event or Problem Description
During surgery, one of the sliding tulips on the oc plate slid off of the plate.The surgeon removed and replaced the entire construct.
 
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Brand Name
NEON3
Common Device Name
OC PLATE
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-württemberg 89081
GM  89081
MDR Report Key8197760
Report Number9612420-2018-00021
Device Sequence Number11205214
Product Code NKG
UDI-Device Identifier04052536161485
UDI-Public4052536161485
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K161032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/26/2018
Report Date (Section F) 12/26/2018
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
Operator of Device Health Professional
Device Model NumberCS 3913-08
Device Catalogue NumberCS 3913-08
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/13/2018
Date Report to Manufacturer12/26/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/26/2018
Initial Report FDA Received Date12/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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