MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, Ø 5.5 MM, LENGTH 50 MM

Model Number	CS 3802-055-050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the follow-up lumbar spine x-ray on (b)(6) 2019 in the outpatient clinic, a screw fracture was detected.There is currently no need for revision surgery.

• Brand Name: UCENTUM
• Common Device Name: SCREW, POLYAXIAL, Ø 5.5 MM, LENGTH 50 MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 9218056
• Report Number: 9612420-2019-00052
• Device Sequence Number: 2106689
• Product Code: NKB
• UDI-Device Identifier: 04052536078783
• UDI-Public: 4052536078783
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K123717
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: CS 3802-055-050
• Device Catalogue Number: CS 3802-055-050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/22/2019
• 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: Hospitalization