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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

Screw came apart during implantation and had to be removed and replaced.

Event 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
• Type of Device: 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
• MDR Text Key: 283091922
• Report Number: 9612420-2021-00012
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536083244
• UDI-Public: 04052536083244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization