MAUDE Adverse Event Report: ULRICH MEDICAL USA SOLIDITY; CENTER PIECE, TURQUOISE, 13MM, HEIGHT 19-27.5MM

Model Number UU041-01-1927

Device Problem Collapse (1099)

Patient Problem Failure of Implant (1924)

Event Date 12/11/2019

Event Type  malfunction  

Event Description

6 week post-op x-rays showed vbr height reduction.No revision surgery has occurred or been scheduled as of this date.The patient's condition is being monitored.

• Brand Name: SOLIDITY
• Type of Device: CENTER PIECE, TURQUOISE, 13MM, HEIGHT 19-27.5MM
• Manufacturer (Section D): ULRICH MEDICAL USA; 18221 edison ave.; chesterfield MO 63005
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; na; ulm, 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 18221 edison ave.; chesterfield, MO 63005 ; 6365190268
• MDR Report Key: 9577962
• MDR Text Key: 215570316
• Report Number: 3005823819-2020-00001
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00814386022293
• UDI-Public: 00814386022293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: UU041-01-1927
• Device Catalogue Number: UU041-01-1927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR