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

Model Number	25-003-14-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event; please see associated report: mdr 9610905-2019-00065, mdr 9610905-2019-00066, mdr 9610905-2019-00067, mdr 9610905-2019-00068, mdr 9610905-2019-00069.Reference exemption number e2017029.
Event or Problem Description
It was reported that product was removed due to patient condition.
Additional Manufacturer Narrative
An investigation could not be performed because no device was returned, and it is unclear what stock number might have caused the problem as multiple devices were reported in the event.The product lot number was not identified; therefore, the device history records were not reviewed.It is unclear which stock number might have caused the problem, therefore complaint rate and review of the risk file were not performed.The failure root cause 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.
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.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.The failure root cause cannot be determined due to the device not 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 NEURO
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8375623
• Report Number: 9610905-2019-00064
• Device Sequence Number: 14004162
• Product Code: JEY
• UDI-Device Identifier: 00888118034861
• UDI-Public: (01)00888118034861
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K944565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2019
• Report Date (Section F): 02/22/2019

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: Health Professional
• Device Model Number: 25-003-14-09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 05/15/2019; 05/15/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 06/11/2019; 06/19/2019
• 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: 71 YR