MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREWDRIVER FOR LOCKING SCREW, COUPLING V

Model Number CS 3851-02

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Report is being submitted past 30 day deadline based on additional information received indicating that it was a reportable event.

Event Description

Surgeon decided to remove system after fusion had occurred.When removing the locking screw the screwdriver tip broke off in the locking screw and could not be removed.The surgeon had to destroy the screw head to be able to remove the system.

• Brand Name: UCENTUM
• Type of Device: SCREWDRIVER FOR LOCKING SCREW, COUPLING V
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 8773544
• MDR Text Key: 150541686
• Report Number: 3005823819-2019-00006
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536081707
• UDI-Public: 4052536081707
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS 3851-02
• Device Catalogue Number: CS 3851-02
• Device Lot Number: U005690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/03/2019
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization