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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 7.5MM, LENGTH 35MM
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ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 7.5MM, LENGTH 35MM Back to Search Results
Model Number CS 3802-075-035
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 09/01/2016
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.
 
Event or Problem Description
Screw breakage.
 
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Brand Name
UCENTUM
Common Device Name
SCREW, POLYAXIAL, 7.5MM, LENGTH 35MM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key5987056
Report Number9612420-2016-00012
Device Sequence Number18852202
Product Code NKB
UDI-Device Identifier04052536078875
UDI-Public4052536078875
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K123717
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 09/29/2016
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 3802-075-035
Device Catalogue NumberCS 3802-075-035
Device Lot NumberWSA14727667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2016
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/01/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/08/2016
Initial Report FDA Received Date09/29/2016
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;
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