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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; PEDICLE PROBE
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ULRICH GMBH & CO. KG UCENTUM; PEDICLE PROBE Back to Search Results
Model Number UL 8527-23
Device Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report is being submitted past 30 day deadline based on retrospective review conducted 6/21/2019.Original mdr (report 1 of 2) filed 11/15/2018.
 
Event Description
The tip of a probe broke off during insertion inside the patient.Retrieving the tip caused approximately a one hour delay of surgery.Report 2/2.
 
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Brand Name
UCENTUM
Type of Device
PEDICLE PROBE
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 Key8745563
MDR Text Key149552264
Report Number9612420-2019-00032
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04052536052936
UDI-Public4052536052936
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 Non-Healthcare Professional
Type of Report Initial
Report Date 11/14/2018,06/25/2019
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 NumberUL 8527-23
Device Catalogue NumberUL 8527-23
Device Lot NumberBEA1656262313
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/22/2018
Date Report to Manufacturer11/14/2018
Date Manufacturer Received11/14/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age70 YR
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