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

Model Number	25-314-85-91
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00248.Reference exemption number e2017029.
Event or Problem Description
It was reported the plates were sitting proud.The plates were removed.
Additional Manufacturer Narrative
An investigation was performed using a stereo microscope revealed surface damage and bending but no breakage.Further observation determined there were no indications of material or manufacturing defects.The risk and device history records were not reviewed as there was no failure found.The investigation results conclude that the root cause is patient related as no device issue was found.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 strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 7939736
• Report Number: 9610905-2018-00247
• Device Sequence Number: 11339173
• Product Code: JEY
• UDI-Device Identifier: 00888118038722
• UDI-Public: (01)00888118038722
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018
• Report Date (Section F): 09/14/2018

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: 25-314-85-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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
• Patient Age: 21 YR
• Patient Weight: 60