MAUDE Adverse Event Report: ULRICH MEDICAL USA SOLIDITY; CENTER PIECE, YELLOW 13MM, HEIGHT 16-21.5MM

Model Number UU041-01-1621

Device Problem Collapse (1099)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

6 week post-op x-rays show vbr height reduction.

• Brand Name: SOLIDITY
• Type of Device: CENTER PIECE, YELLOW 13MM, HEIGHT 16-21.5MM
• 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
• MDR Report Key: 9526660
• MDR Text Key: 202058914
• Report Number: 3005823819-2019-00012
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00814386022286
• UDI-Public: 00814386022286
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UU041-01-1621
• Device Catalogue Number: UU041-01-1621
• Device Lot Number: U019366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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