MAUDE Adverse Event Report: ULRICH MEDICAL GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 6.5MM, LENGTH 50MM, PERFORATED

Model Number	CS 3802-065-050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Spondylodesis l5 / s1 on 2020-02-18 with ucentum and tezo t in therapy-resistant lumboischialgia left.Renewed, pain-related presentation of the patient already 10 days after surgery, suspected malignant myeloma.Detection of a follow-up degeneration in (b)(6) 2020.Revisional intervention due to degeneration of the connection and relocation to cranial on (b)(6) 2020.X-ray image now shows fracture of the s1 screw on the left, below the tulip.Intraoperatively, the s1 screw on the right, below the tulip, also broke when the cover screws were loosened.Exchange of screws in s1, and extension to l4 with ucentum and tezo t.
Event or Problem Description
Screw breakage.See manufacturer narrative for details.Report 2 of 2.

• Brand Name: UCENTUM
• Common Device Name: SCREW, POLYAXIAL, 6.5MM, LENGTH 50MM, PERFORATED
• Manufacturer (Section D): ULRICH MEDICAL GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 10819706
• Report Number: 3005823819-2020-00018
• Device Sequence Number: 4246707
• Product Code: NKB
• UDI-Device Identifier: 04052536078844
• UDI-Public: 4052536078844
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2020
• Report Date (Section F): 09/08/2020

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: No Information
• Device Model Number: CS 3802-065-050
• Device Catalogue Number: CS 3802-065-050
• Device Lot Number: U008099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/08/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2020
• 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: Required Intervention
• Date Report Sent to FDA: 09/08/2020