MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; SCREW

Model Number 25-878-05-91

Device Problems Break (1069); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/03/2016

Event Type  Injury  

Event Description

The doctor was repairing an infraorbital rim fracture in the patient.After drilling a pilot hole, she then proceeded to place the screw into the predrilled hole.The screw snapped off slightly before the screw head reached the plate.The body of the screw remains in the patient.No reported injuries occurred.

Manufacturer Narrative

An investigation was performed using visual and stereo microscope inspection of the screw head returned.Tensile cracks were observed under the stereo microscope.Further observation determined there were no indications of material or manufacturing defects.The device history records could not be reviewed since no lot number was provided by the reporter.The results of the investigation conclude that the root cause for the breakages were due to mechanical overload on the device.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE CMF
• Type of Device: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 6291327
• MDR Text Key: 66214336
• Report Number: 9610905-2017-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888118047694
• UDI-Public: (01)00888118047694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-878-05-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2016
• 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): Other
• Patient Age: 48 YR