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

Model Number	25-322-71-09
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
Three plates that affixed a peek cranioplasty implant broke after implantation.Broken plates were removed on (b)(6) 2017, during the same procedure the doctor re-implanted the same peek implant with new plates and screws.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the product returned.Process evaluation was also performed based off the lot number provided.The returned (b)(4) revealed stretching/ bending in the areas of the screw holes and breakage.The breakage areas revealed tensile fractures due to mechanical stress.It was not possible to determine a root cause for this case.During the investigation the product lot numbers provided was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.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: 7053117
• Report Number: 9610905-2017-00087
• Device Sequence Number: 86177
• Product Code: JEY
• UDI-Device Identifier: 00888118038890
• UDI-Public: (01)00888118038890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944565
• 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): 10/26/2017
• Report Date (Section F): 10/26/2017

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: 25-322-71-09
• Device Lot Number: 32483871, 33186654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/20/2017
• 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: 30 YR