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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SET SCREW
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ULRICH GMBH & CO. KG UCENTUM; SET SCREW Back to Search Results
Model Number CS 3801-01
Device Problem Device Handling Problem (3265)
Patient Problem Failure of Implant (1924)
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report is being submitted past 30 day deadline based on retrospective review conducted on 6/21/2019.Original mdr (report 1 of 4) filed 12/26/2018.
 
Event Description
Set screws would not engage the pedicle screw.Report 2/4.
 
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Brand Name
UCENTUM
Type of Device
SET SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
Manufacturer (Section G)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
na
ulm, 89081
GM   89081
Manufacturer Contact
christoph ulrich
buchbrunnenweg 12
na
ulm, baden-württemberg 89081
GM   89081
MDR Report Key8745573
MDR Text Key149551953
Report Number9612420-2019-00033
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04052536078646
UDI-Public4052536078646
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2018,06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCS 3801-01
Device Catalogue NumberCS 3801-01
Device Lot NumberU017815
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/29/2018
Date Report to Manufacturer12/12/2018
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age69 YR
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