MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; LONGARM SCREW, PRE-FIXATION, 7.5MM, LENGTH 50MM

Model Number CS 3805-075-050

Device Problems Break (1069); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Surgeon was inserting screw using a powered screwdriver and screwed it too far into the bone.The screw head broke off from the tulip and the broken pieces were removed and replaced.This caused a delay in surgery and the patient reported post-operative pain and discomfort that the surgeon attributed to this event.

• Brand Name: UCENTUM
• Type of Device: LONGARM SCREW, PRE-FIXATION, 7.5MM, LENGTH 50MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchrunnenweg 12; ulm, 89081 ; GM 89081
• MDR Report Key: 6905882
• MDR Text Key: 87846300
• Report Number: 9612420-2017-00024
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536079926
• UDI-Public: 4052536079926
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CS 3805-075-050
• Device Catalogue Number: CS 3805-075-050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2017
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 70 YR