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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREW, PRE-FIXATION
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ULRICH GMBH & CO. KG UCENTUM; SCREW, PRE-FIXATION Back to Search Results
Model Number CS 3804-065-045
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Discomfort (2330)
Date of Event 02/28/2018
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
Two pre-fixation screws in s1 broke (one directily underneath the screw head and the other at the middle of the thread).A revision was done to replace the broken screws.
 
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Brand Name
UCENTUM
Common Device Name
SCREW, PRE-FIXATION
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key7626966
Report Number9612420-2018-00009
Device Sequence Number18883088
Product Code NKB
UDI-Device Identifier04052536079551
UDI-Public4052536079551
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K123717
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/21/2018
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 No Information
Device Model NumberCS 3804-065-045
Device Catalogue NumberCS 3804-065-045
Device Lot NumberU003865 & U010958
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/18/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/28/2018
Initial Report FDA Received Date06/21/2018
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; Required Intervention;
Patient Age74 YR
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