MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. MAXDRIVE MINI SCREW; BONE SCREW

Model Number 25-872-09-09

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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/05/2015

Event Type  Injury  

Event Description

During implantation, the screw heads broke and sheered off.The remaining portion of the screw shafts were unable to be explanted and remain in the patient's bone.No secondary surgery is scheduled for screw removal.

Manufacturer Narrative

The screws were 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 were also reviewed based on the lot number provided and revealed no abnormalities.The results of the investigation conclude that the root cause for breakage was due to a mechanical overload on the screws.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: MAXDRIVE MINI SCREW
• Type of Device: BONE SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO.; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO.; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 5173587
• MDR Text Key: 29185741
• Report Number: 9610905-2015-00052
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K943347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

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: No Information
• Device Model Number: 25-872-09-09
• Device Lot Number: 32937855
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• 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