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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG GOLDEN GATE; SCREW, LENGTH 35MM
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ULRICH GMBH & CO. KG GOLDEN GATE; SCREW, LENGTH 35MM Back to Search Results
Model Number CS 3608-035
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/08/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer).Exemption # e2014011.Report is being submitted past 30 day deadline based on retrospective review conducted 6/27/2019.
 
Event or Problem Description
Threads on the screw sheered off during implantation.Metal sliver found and discarded.
 
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Brand Name
GOLDEN GATE
Common Device Name
SCREW, LENGTH 35MM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key8745571
Report Number9612420-2019-00038
Device Sequence Number16561094
Product Code KWQ
UDI-Device Identifier04052536019267
UDI-Public4052536019267
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K101353
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/27/2019
Report Date (Section F) 01/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberCS 3608-035
Device Catalogue NumberCS 3608-035
Device Lot NumberWSA14720419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/08/2016
Date Report to Manufacturer01/08/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/08/2016
Initial Report FDA Received Date06/28/2019
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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