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

Model Number 25-872-15-91

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2015

Event Type  Injury  

Event Description

The doctor was inserting the screw into the patient's mandible with a 2.0 locking plate, using a black handle ratchet screwdriver, and the screw broke mid shaft.The top half was thrown away by the tech, and the bottom half remains in the patient.

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.Due to no physical device available for evaluation, the reported incident cannot be appropriately validated and the root cause cannot be determined.If further information can be gathered that might add value to the content 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. 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: 5278977
• MDR Text Key: 33076940
• Report Number: 9610905-2015-00069
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-872-15-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2015
• 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: 36 YR