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

Model Number	25-301-04-09
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two related mdrs.Please refer to mdr 9610905-2017-00019.Both mdr's are submitted for the same patient and event however due to two different devices involved separate mdr's are being filed.Patient information was requested from the hospital, however they are not releasing the information.The exact event date is unknown.It was reported to have occurred sometime during the week of (b)(6) 2017.Device lot is unknown at this time.Device was implanted in (b)(6) 2016, the exact date of implantation is unknown.Device was explanted during the week of (b)(6) 2017, however exact date is unknown.
Event or Problem Description
Dr.(b)(6) placed the orthoanchor plates last (b)(6) 2016 and discovered they were broken during the week of (b)(6) 2017.The plates were removed.
Additional Manufacturer Narrative
An investigation was performed using visual and stereo inspection on the returned product.Tensile cracks were observed under the stereo microscope.Further investigation determined that there was no indication of material or manufacturing defects observed.The device lot number was not provided by the customer therefor the device history records could not be reviewed.The investigation results concluded that the root cause for breakages were due to structural failure of the device due to mechanical overload.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 ORTHOANCHOR
• Common Device Name: ORTHOANCHOR PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6354771
• Report Number: 9610905-2017-00032
• Device Sequence Number: 1577089
• Product Code: DZE
• UDI-Device Identifier: 00888118037558
• UDI-Public: (01)00888118037558
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K040891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2017

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: 25-301-04-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: 01/27/2017
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 09/13/2017
• 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