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

Model Number	50-774-20-09
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a pathologic fracture due to mandibular atrophy.Patient was treated with radiation for a cancerous mandibular lesion in the same area prior to the fracture.Patient had undergone a series of hyperbaric oxygen therapy prior to surgery.Upon completion of radiation the patient had complained of tenderness on the left side of his jaw.X-ray was taken which demonstrated a pathologic fracture of the left mandible close to the mandibular angle.On (b)(6) 2017 patient underwent surgery and a ts locking plate was implanted.Surgery was successful with reduction and application of the plate with locking screws.Surgery and healing was uneventful until (b)(6) 2017 when the patient complained that while he was chewing he heard a popping noise.Patient was wearing upper and lower dentures at the time this occurred.Post-operative x-ray during his exam revealed the locking plate had fracture at the initial fracture site.The doctor planned to take him back to the operating room and position our external fixator, which was to occur on (b)(6) 2017.Patient cancelled surgery to get a second opinion.Plate still remains in patient.Doctor reported patient is not in any pain at this time.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated and it is 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 based on the lot number provided.In the investigation no anomalies were discovered.Due to no 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: 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: 6419026
• Report Number: 9610905-2017-00033
• Device Sequence Number: 647996
• Product Code: MQN
• UDI-Device Identifier: 00888118078377
• UDI-Public: (01)00888118078377
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K032442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2017

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: 50-774-20-09
• Device Lot Number: 31036778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 05/18/2017
• 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: 76 YR