MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; LONGARM SCREW, POLYAXIAL, 8.5MM, LENGTH 45MM, NON CANNULATED

Model Number	CS 3885-085-045
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Screw came apart during implantation and had to be removed and replaced.
Event or Problem Description
Mdr should not have been submitted.After getting ahold of the user we discovered that the pedicle screw came apart prior to surgery, not in the surgical field, and there was no effect on the patient.

• Brand Name: UCENTUM
• Common Device Name: LONGARM SCREW, POLYAXIAL, 8.5MM, LENGTH 45MM, NON CANNULATED
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 12749076
• Report Number: 3005823819-2021-00028
• Device Sequence Number: 4489680
• Product Code: NKB
• UDI-Device Identifier: 04052536083244
• UDI-Public: 04052536083244
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022
• Report Date (Section F): 10/18/2021

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 Model Number: CS 3885-085-045
• Device Catalogue Number: CS 3885-085-045
• Device Lot Number: U017218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2021
• Date Report to Manufacturer: 10/18/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 01/28/2022
• 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
• Patient Sex: Unknown