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

Device Problem Loss of Osseointegration (2408)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple attempts have been made to obtain stock/lot number of the screws, however, at this time it is unknown.Patient involved in multiple mdrs: 9610905-2018-00214, 9610905-2018-00215, 9610905-2018-00217, 9610905-2018-00218, 9610905-2018-00219, 9610905-2018-00220, 9610905-2018-00221, 9610905-2018-00222, 9610905-2018-00223, 9610905-2018-00224.

Event Description

It was reported screws were loose due to patient condition.The screws were removed.

Manufacturer Narrative

Device material number nor lot number was identified therefore complaint rate, review of device history records and risk file was not possible.The root cause for the failure cannot be determined since neither material nor lot number were provided.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 CMF
• Type of Device: PLATE
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 7856084
• MDR Text Key: 119551700
• Report Number: 9610905-2018-00216
• Device Sequence Number: 1
• Product Code: JEY
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2018
• Date Manufacturer Received: 12/14/2018
• 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
• Patient Age: 44 YR
• Patient Weight: 95