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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 55MM
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ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 6.5MM, LENGTH 55MM Back to Search Results
Model Number CS 3802-065-055
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event 12/18/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Approximately 16 months post-op, x-rays revealed non-union.A revision surgery was done to remove all hardware and found one screw and one rod were broken.Report 1 of 2.
 
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Brand Name
UCENTUM
Common Device Name
SCREW, POLYAXIAL, 6.5MM, LENGTH 55MM
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key9591580
Report Number3005823819-2020-00002
Device Sequence Number16257934
Product Code NKB
UDI-Device Identifier04052536078851
UDI-Public4052536078851
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/14/2020
Report Date (Section F) 01/07/2020
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 3802-065-055
Device Catalogue NumberCS 3802-065-055
Device Lot NumberUD12544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/18/2019
Event Location Hospital
Date Report to Manufacturer01/07/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/15/2020
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 Age53 YR
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