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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH MEDICAL GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL
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ULRICH MEDICAL GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL Back to Search Results
Model Number CS 3802-055-040
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/13/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Screw clamping plate disassociated from screw during surgery.Screw was removed and replaced.
 
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Brand Name
UCENTUM
Common Device Name
SCREW, POLYAXIAL
Manufacturer (Section D)
ULRICH MEDICAL GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key11140325
Report Number9612420-2021-00001
Device Sequence Number3950188
Product Code NKB
UDI-Device Identifier04052536078769
UDI-Public04052536078769
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K123717
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 10/29/2021
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 3802-055-040
Device Catalogue NumberCS 3802-055-040
Device Lot NumberU011293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Initial Date Received by Manufacturer 12/10/2020
Supplement Date Received by Manufacturer12/10/2020
Initial Report FDA Received Date01/08/2021
Supplement Report FDA Received Date10/29/2021
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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