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

Model Number 25-308-00-91

Device Problem Failure to Osseointegrate (1863)

Patient Problems Impaired Healing (2378); Inadequate Osseointegration (2646)

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 9610905-2018-00025; and mdr 9610905-2018-00032.

Event Description

It was reported the plates and screws were removed due to loose screws.

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: 7317600
• MDR Text Key: 101633273
• Report Number: 9610905-2018-00033
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118038258
• UDI-Public: (01)00888118038258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944565
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 25-308-00-91
• 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: 02/28/2018
• Date Manufacturer Received: 02/28/2018
• 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