MAUDE Adverse Event Report: ULRICH MEDICAL USA SOLIDITY; INSERTER

Model Number	UU042-03-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon tried to manipulate the implant medially to reposition and the inserter became disengaged from the implant and hit the patient.The patient experienced a dural tear.

• Brand Name: SOLIDITY
• Common Device Name: INSERTER
• Manufacturer (Section D): ULRICH MEDICAL USA; 18221 edison ave.; chesterfield MO 63005
• MDR Report Key: 12345470
• Report Number: 3005823819-2021-00023
• Device Sequence Number: 4535718
• Product Code: MQP
• UDI-Device Identifier: 00814386022552
• UDI-Public: 00814386022552
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UU042-03-01
• Device Catalogue Number: UU042-03-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other