MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG IPS, CRANIAL IMPLANT; PLATE

Model Number	60-000-23-09
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Multiple mdr reports were filed for this patient, please see report: mdr 9610905-2018-00133; mdr 9610905-2018-00134; mdr 9610905-2018-00135.
Event or Problem Description
It was reported plates and screws failed.Devices are planned to be removed in august.
Additional Manufacturer Narrative
New information - explant date.Multiple mdr reports were filed for this patient, please see report: mdr 9610905-2018-00133, mdr 9610905-2018-00134, mdr 9610905-2018-00135.
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 identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.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.

• Brand Name: IPS, CRANIAL IMPLANT
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau 78570 ; GM 78570
• MDR Report Key: 7706935
• Report Number: 9610905-2018-00132
• Device Sequence Number: 1329474
• Product Code: GXN
• UDI-Device Identifier: 00888118100139
• UDI-Public: (01)00888118100139
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072707
• 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): 06/27/2018
• Report Date (Section F): 06/27/2018

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: Health Professional
• Device Model Number: 60-000-23-09
• Device Lot Number: 17006228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 12/05/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/27/2018; 12/18/2018
• 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