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

Model Number	25-322-71-71
Medical Device Problem Codes	Device Issue (2379); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Multiple mdr reports were filed for this event, please see associated report: mdr 9610905-2018-00052, mdr 9610905-2018-00054.
Event or Problem Description
It was reported that after the patient received radiation the plate may have broken and needs to be removed and replaced.Expected removal date (b)(6) 2018.
Additional Manufacturer Narrative
An investigation was performed using a stereo microscope which revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.A review of the device history records was not possible due to no lot number identified.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.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 NEURO
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 7506051
• Report Number: 9610905-2018-00053
• Device Sequence Number: 1529167
• Product Code: JEY
• UDI-Device Identifier: 00888118038906
• UDI-Public: (01)00888118038906
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2018
• Report Date (Section F): 04/16/2018

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: 25-322-71-71
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/24/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 07/25/2018; 09/18/2018
• 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