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

Model Number	60-000-66-09
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had lefort i and bilateral sagittal split osteotomies.Patient specific plates were placed in both the right and left side of the maxilla and mandible.Patient had an infection in right mandibular plate.Both left and right mandibular implants were removed due to concern by dr.(b)(6).Two screws were noticed to be loose when plate was removed.It was noted the patient did not have the best oral hygiene and did not keep the site clean.Maxilla plates were left implanted.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the device returned.Process evaluation was also performed based off the lot number provided.The stereo microscope investigation revealed no cracks or breakage of the device.Further observation determined there were no indications of material or manufacture defects.A review of the product device history files was performed based on the lot number provided.No discrepancies were found in this investigation.All records determined that the device was not sold as sterile.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
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6335660
• Report Number: 9610905-2017-00014
• Device Sequence Number: 13670232
• Product Code: MQN
• UDI-Device Identifier: 00888118095473
• UDI-Public: (01)00888118095473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032442
• 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): 01/19/2017

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: 60-000-66-09
• Device Lot Number: #8661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 06/12/2017
• 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: 28 YR