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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH MEDICAL USA UNION; UNION STANDARD CERVICAL PLATE, 1-LEVEL, 18 MM
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ULRICH MEDICAL USA UNION; UNION STANDARD CERVICAL PLATE, 1-LEVEL, 18 MM Back to Search Results
Model Number UM102-01-18
Medical Device Problem Codes Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes Failure of Implant (1924); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event 11/01/2019
Type of Reportable Event Malfunction
Event or Problem Description
X-rays approximately 8 months post op revealed plate's locking mechanism had detached from the plate and that the locking mechanism had migrated in the patient.No revision is scheduled, patient condition is being monitored.
 
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Brand Name
UNION
Common Device Name
UNION STANDARD CERVICAL PLATE, 1-LEVEL, 18 MM
Manufacturer (Section D)
ULRICH MEDICAL USA
18221 edison ave.
chesterfield MO 63005
MDR Report Key9598495
Report Number3005823819-2020-00004
Device Sequence Number2525598
Product Code KWQ
UDI-Device Identifier00814386020046
UDI-Public00814386020046
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K150666
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
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? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberUM102-01-18
Device Catalogue NumberUM102-01-18
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/20/2019
Supplement Date Received by Manufacturer12/20/2019
Initial Report FDA Received Date01/16/2020
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 Other;
Patient Age40 YR
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