MAUDE Adverse Event Report: KARL LEIBINGER GMBH &. CO. KG MAXILLOMANDIBULAR FIXATION SCREW

Model Number 25-092-12-91

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/16/2015

Event Type  Injury  

Event Description

During implantation, the screw broke off in the pt's maxilla and the remaining portion still resides in the pt's bone.Pt will not require add'l surgery due to breakage.The broken screw was discarded and will not be available for eval.

Manufacturer Narrative

There was no device returned for eval and no add'l info provided related to this event.Prod history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the mfg documentation.For this reason, steps could not be taken to replicate or confirm the reported event.The root cause is unk at this time.If further info is acquired that adds value to the content of this report and/or a valid conclusion can be drawn, a f/u report will be sent.

• Brand Name: MAXILLOMANDIBULAR FIXATION SCREW
• Type of Device: FIXATION SCREW
• Manufacturer (Section D): KARL LEIBINGER GMBH &. CO. KG; kolbinger str. 10; muhlheim/donau 7857 0; GM 78570
• Manufacturer (Section G): KARL LEIBINGER GMBH & CO. KG; kolbinger str. 10; muhlheim/donau 7857 0; GM 78570
• Manufacturer Contact: jennifer damato ; po box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 4619401
• MDR Text Key: 18933201
• Report Number: 9610905-2015-00012
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-092-12-91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• 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 Age: 55 YR