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

Model Number 25-872-07-91

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2016

Event Type  Injury  

Event Description

The surgeon was plating a left angle fracture when the screw head fractured off.The remainder of the screw is still in the patients mandible.There were no consequences to the patient besides the rest of the screw being left in the mandible.

Manufacturer Narrative

Visual inspection by stereo microscope was performed.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 the lot number was provided by the reporter.The results of the investigation conclude that the root cause for breakages were due to mechanical overload on the device.If further information can be gathered 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: 6147379
• MDR Text Key: 61538444
• Report Number: 9610905-2016-00043
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118046734
• UDI-Public: (01)00888118046734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943347
• 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: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-872-07-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• 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: 23 YR