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

Model Number 25-092-52-91

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/21/2015

Event Type  Injury  

Event Description

The screw broke off at the screw head during implantation.Surgeon had to burr the screw down slightly on the bone to try and grasp the screw shaft.The shaft of the screw was unable to be removed from the patient's mandible and was sutured over.No secondary surgery is scheduled for screw removal.The screw head was thrown away by the hospital and is not available for return.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was sent back for evaluation.It is determined that the complaint percentage falls well within the product risk limits that are adhered to at klm.In addition to no device being returned, product history records could not be reviewed because no lot number or any identification traceable to the manufacturing documentation was provided.Due to no device being returned and no lot number provided, the root cause for the breakage cannot be determined.If further information can be gathered that can add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: MMF SCREW
• Type of Device: FIXATION 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: 5199420
• MDR Text Key: 30327822
• Report Number: 9610905-2015-00055
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083432
• 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: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-092-52-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• 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): Other
• Patient Age: 42 YR