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

Model Number 01-335-06-09

Device Problem Failure to Osseointegrate (1863)

Patient Problems Erosion (1750); Impaired Healing (2378); Patient Problem/Medical Problem (2688)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event and patient, please see associated report: mdr 9610905-2018-00024; mdr 9610905-2018-00032; and mdr 9610905-2018-00033.

Event 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.".

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
• Type of Device: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 7309585
• MDR Text Key: 101376503
• Report Number: 9610905-2018-00025
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118006097
• UDI-Public: (01)00888118006097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Model Number: 01-335-06-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 75