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

Event Description

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

Event 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
• Type of Device: 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
• MDR Text Key: 280065554
• Report Number: 3005823819-2021-00028
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536083244
• UDI-Public: 04052536083244
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2021,01/28/2022

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2021
• Date Report to Manufacturer: 10/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization