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

Model Number 25-090-12-91

Device Problems Detachment Of Device Component (1104); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2016

Event Type  Injury  

Event Description

Screw head was twisted off while the surgeon was placing it into the patient's maxilla.The shaft of the screw remains in the patient's bone.No secondary surgery is scheduled for screw shaft removal.

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, device history records could not be reviewed because the reporter did not provide any lot number or traceable identification to conduct a proper investigation.Due to no device being returned and no lot number provided, the root cause for the failure 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: MMF 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: 5405438
• MDR Text Key: 37337131
• Report Number: 9610905-2016-00003
• 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
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-090-12-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• 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