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

Model Number	24-015-25-71
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Two possible lot numbers identified- 33165753 and 33164207.
Event or Problem Description
It was reported that a plate broke.There are no plans to remove the plate at this time.Ifu (b)(4) states "the surgeon must ensure the fractured segments have bone to bone contact.Any bridging of a continuity defect must be combined with a bone graft".
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.Manufacturing dates: 33165753 15 june 2016; 33164207 17 june 2016.

• Brand Name: LEVEL ONE THORACIC
• Common Device Name: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 7877975
• Report Number: 9610905-2018-00213
• Device Sequence Number: 2077028
• Product Code: HRS
• UDI-Device Identifier: 00888118092540
• UDI-Public: (01)00888118092540
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018
• Report Date (Section F): 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24-015-25-71
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1