MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; LONGARM SCREW, POLYAXIAL, Ø 8.5 MM, LENGTH 45 MM, NOT 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	Malfunction
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 a hold 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, Ø 8.5 MM, LENGTH 45 MM, NOT CANNULATED
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer Contact: andreas hilzenbecher ; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• MDR Report Key: 12749075
• Report Number: 9612420-2021-00012
• Device Sequence Number: 19953342
• Product Code: NKB
• UDI-Device Identifier: 04052536083244
• UDI-Public: 04052536083244
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123717
• 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: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown