MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG PCI PRE-BENT PLATE; MANDIBULAR PLATE

Model Number	60-650-01-04
Health Effect - Clinical Codes	Cyst(s) (1800); Sensitivity of Teeth (2427)
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon used the 3mm pre-bent locking plate after surgical removal of an ameloblastoma.After the case the patient resection showed a positive margin.The surgeon had to perform additional surgery to complete the removal of the ameloblastoma, pre-bent plate was removed and replaced.
Additional Manufacturer Narrative
Lot # was updated to include lot number as it was previously unknown.An investigation was performed on the basis of complaint statistics and data analysis 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.The product history device records were also reviewed based on the lot number and revealed no abnormalities.Due to now device being returned the root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: PCI PRE-BENT PLATE
• Common Device Name: MANDIBULAR PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6147445
• Report Number: 9610905-2016-00046
• Device Sequence Number: 893433
• Product Code: MQN
• UDI-Device Identifier: 00888118095015
• UDI-Public: (01)00888118095015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2016

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
• Operator of Device: Physician
• Device Model Number: 60-650-01-04
• Device Lot Number: #8438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR