MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREW, POLYAXIAL, 06.5MM, LENGTH 55MM

Model Number CS 3802-065-055

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Screw breakage in s1.

• Brand Name: UCENTUM
• Type of Device: SCREW, POLYAXIAL, 06.5MM, LENGTH 55MM
• 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 ; 7319654 16
• MDR Report Key: 5261163
• MDR Text Key: 32509215
• Report Number: 9612420-2015-00014
• Device Sequence Number: 1
• Product Code: NKB
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CS 3802-065-055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2015
• Device Age: 2 YR
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention