MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG MMF SCREW; BONE SCREW

Model Number 25-092-12-91

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/06/2016

Event Type  Injury  

Event Description

The screw head broke off during implantation.The shaft of the screw remains in the patient's mandible.No secondary surgery is scheduled for screw shaft removal.

Manufacturer Narrative

The screw head was optically assessed and stereo microscopically investigated in the lab.The stereo microscopic investigation revealed a tensile crack due to mechanical overload.Further observation determined there were no indications of material or manufacturing defects discovered.Product device history records could not be reviewed because no lot number or any other traceable identification was provided.The results of the investigation conclude that the root cause for breakage was due to mechanical overload on the screw.If further information can be gathered that might add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: MMF SCREW
• Type of Device: BONE 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: 5594105
• MDR Text Key: 43205578
• Report Number: 9610905-2016-00011
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00888118037220
• UDI-Public: 00888118037220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042573
• 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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-092-12-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• 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: 34 YR