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

Model Number 25-092-08-09

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

Device was not available for return; therefore, no proper evaluation could be performed.Product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.As a result, steps could not be taken to replicate or confirm the reported event.The root cause cannot be determined at this time.If further information is acquired that adds value to the content of this report and/or a valid conclusion can be drawn, a follow-up report will be sent.Device was not available for return.

Event Description

During implantation, the screw broke off at the shaft.A portion of the screw shaft still remains in the patient's maxilla.No secondary surgery is scheduled to remove the screw shaft from the patient's bone.

• Brand Name: MMF SCREW
• Type of Device: BONE 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: 5000325
• MDR Text Key: 22856087
• Report Number: 9610905-2015-00039
• Device Sequence Number: 1
• Product Code: DZL
• 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
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-092-08-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR