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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 6.5MM, LENGTH 45MM
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ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 6.5MM, LENGTH 45MM Back to Search Results
Model Number CS 3802-065-045
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/12/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional information to h3: the device is at the our sterilization supplier now; we will start the evaluation after the sterilization.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, 6.5MM, LENGTH 45MM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key6614152
Report Number9612420-2017-00015
Device Sequence Number1049235
Product Code NKB
UDI-Device Identifier04052536078837
UDI-Public4052536078837
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K123717
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/02/2017
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? Yes
Operator of Device No Information
Device Model NumberCS 3802-065-045
Device Catalogue NumberCS 3802-065-045
Device Lot NumberU012546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/22/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/12/2017
Initial Report FDA Received Date06/06/2017
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;
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