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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG NEON3; SCREW, LONGSHAFT, CANNULATED, 4.0MM, LENGTH 32MM
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ULRICH GMBH & CO. KG NEON3; SCREW, LONGSHAFT, CANNULATED, 4.0MM, LENGTH 32MM Back to Search Results
Model Number CS 3904-40-32
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/23/2017
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
Screw breakage.
 
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Brand Name
NEON3
Common Device Name
SCREW, LONGSHAFT, CANNULATED, 4.0MM, LENGTH 32MM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key6411319
Report Number9612420-2017-00008
Device Sequence Number1102547
Product Code NKG
UDI-Device Identifier04052536084326
UDI-Public4052536084326
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K150650
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/16/2017
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 No Information
Device Model NumberCS 3904-40-32
Device Catalogue NumberCS 3904-40-32
Device Lot NumberU009004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/16/2017
Device Age16 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/17/2017
Initial Report FDA Received Date03/16/2017
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 Required Intervention;
Patient Age45 YR
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