MAUDE Adverse Event Report: ULRICH MEDICAL USA UNION; SELF DRILLING VARIABLE SCREW

Model Number	UM150-40-14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report is being submitted past 30 day deadline based on retrospective review conducted on 6/27/2019.
Event or Problem Description
Metal shaving sheered off of screws during insertion.The shavings were removed and the screws left in place.Report 1/2.

• Brand Name: UNION
• Common Device Name: SELF DRILLING VARIABLE SCREW
• Manufacturer (Section D): ULRICH MEDICAL USA; 18221 edison ave.; chesterfield MO 63005
• MDR Report Key: 8745558
• Report Number: 3005823819-2019-00003
• Device Sequence Number: 11095368
• Product Code: KWQ
• UDI-Device Identifier: 00814386020947
• UDI-Public: 00814386020947
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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 Number: UM150-40-14
• Device Catalogue Number: UM150-40-14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1