MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG MAXDRIVE MINI SCREW; FIXATION SCREW

Model Number 25-872-13-91

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2014

Event Type  Injury  

Event Description

During implantation the screw head snapped off when approximately 10mm of the screw was implanted.The remaining screw shaft still resides within the patient's mandible and was unable to be removed.

Manufacturer Narrative

Device is not available for evaluation.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.

• Brand Name: MAXDRIVE MINI SCREW
• Type of Device: FIXATION SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG; kolbinger str. 10; muhlheim/donau 7857 0; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG; kolbinger strasse 10; muhlheim/donau 7857 0; GM 78570
• Manufacturer Contact: jennifer damato, kls-martin l.p. ; p.o box 16369; jacksonville, FL 32245-7857 ; 9046417746
• MDR Report Key: 4360262
• MDR Text Key: 5116673
• Report Number: 9610905-2014-00030
• Device Sequence Number: 1
• Product Code: JEY
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2014

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: Health Professional
• Device Model Number: 25-872-13-91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 93 YR