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

Model Number	25-879-05-91
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Erosion (1750); Impaired Healing (2378); Inadequate Osseointegration (2646); Patient Problem/Medical Problem (2688)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.Multiple mdr reports were filed for this event and patient, please see associated report: mdr 9610905-2018-00025; mdr 9610905-2018-00032; and mdr 9610905-2018-00033.
Event or Problem Description
It was reported that plates and screws were removed due to patient condition, osteonecrosis of the bone.Ifu (b)(4) contraindications include "patient conditions including: blood supply limitations, insufficient quantity or quality of bone or latent infections.".
Additional Manufacturer Narrative
An investigation was performed using visual and stereo microscopic inspection on the product returned.There were no indications of material or manufacturing defects.The results of the investigation have concluded that no failure 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.Product for this patient is captured on mdr 9610905-2018-00024; mdr 9610905-2018-00025; mdr 9610905-2018-00032; and mdr 9610905-2018-00033 and follow ups.

• Brand Name: LEVEL ONE CMF
• Common Device Name: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 7309546
• Report Number: 9610905-2018-00024
• Device Sequence Number: 19135552
• Product Code: HRS
• UDI-Device Identifier: 00888118047755
• UDI-Public: (01)00888118047755
• 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: 2017
• 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): 01/31/2018
• Report Date (Section F): 01/31/2018

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: Physician
• Device Model Number: 25-879-05-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/16/2018
• 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; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 75