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

Model Number	60-000-72-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported the ips orthognathic plate broke during placement.A back up plate was available to replace the broken plate and the case was completed.
Additional Manufacturer Narrative
An investigation was performed using visual inspection, stereo microscopic inspection, and device history files based on the lot numbers for the broken plate returned.The investigation results conclude that there were no manufacturing or material defects.Reason for breakage could not be ascertained.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Case number - (b)(4) encompasses multiple serial numbers.All were reviewed during the device history review.

• Brand Name: IPS
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6649534
• Report Number: 9610905-2017-00050
• Device Sequence Number: 1285855
• Product Code: GXN
• UDI-Device Identifier: 00888118100740
• UDI-Public: (01)00888118100740
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062570
• 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): 05/17/2017
• Report Date (Section F): 05/17/2017

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: 60-000-72-09
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 11/23/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: 62 YR