MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG LEVEL ONE CMF; PLATE

Model Number	50-405-09-09
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the plate began fracturing therefore event date could not be determined.(b)(4).Reference exemption number e2017029.
Event or Problem Description
Patient complained of mobility of the maxilla after initial surgery (elective orthognathic surgery) and upon x-ray examination, a broken plate was identified.Surgeon was planning a revision due to patient having a class i occlusion following first surgery and suspects this caused the plate to break.Patient did not hear or feel plate breaking and was compliant according to the surgeon.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics and data analysis as no device was returned for evaluation.The complaint percentage was calculated and determined that the complaint percentage falls within the design risk limits adhered to at klm.The review of the product device history records was performed on the lot number provided.In this investigation no anomalies were discovered.The root cause for the failure cannot be determined due to no device being returned.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: LEVEL ONE CMF
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6591436
• Report Number: 9610905-2017-00043
• Device Sequence Number: 11007623
• Product Code: JEY
• UDI-Device Identifier: 00888118076182
• UDI-Public: (01)00888118076182
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K943347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017
• Report Date (Section F): 04/25/2017

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: 50-405-09-09
• Device Lot Number: 33182607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2017
• Date Report to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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: 23 YR