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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM PEDICLE SCREW

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ULRICH GMBH & CO. KG UCENTUM PEDICLE SCREW Back to Search Results
Model Number CS 3802-065-050
Device Problem Device Handling Problem (3265)
Patient Problem Failure of Implant (1924)
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Set screws would not engage the pedicle screw.

 
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Brand NameUCENTUM
Type of DevicePEDICLE SCREW
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-württemberg 89081
GM 89081
Manufacturer (Section G)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
na
ulm, baden-württemberg 89081
GM 89081
Manufacturer Contact
christoph ulrich
buchbrunnenweg 12
na
ulm, baden-württemberg 89081
GM   89081
MDR Report Key8197766
MDR Text Key131442328
Report Number9612420-2018-00020
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/12/2018,12/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCS 3802-065-050
Device Catalogue NumberCS 3802-065-050
Device LOT NumberU0000888
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/29/2018
Event Location No Information
Date Report TO Manufacturer12/12/2018
Date Manufacturer Received12/12/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/26/2018 Patient Sequence Number: 1
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