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

Model Number SEE H10

Device Problem Loss of Osseointegration (2408)

Patient Problem Impaired Healing (2378)

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Possible screw part number - 25-873-47-91 or 25-882-07-91.

Event Description

It was reported that a screw was loose due to bone quality.It was removed and replaced.

Manufacturer Narrative

An investigation was performed using a stereo microscope revealed surface damage.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.The review of the device history records was not possible due to no lot number being identified.The root cause cannot be determined due to no device failure detected or described.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: SCREW
• 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: 7899059
• MDR Text Key: 121055499
• Report Number: 9610905-2018-00229
• 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: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE H10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2018
• Date Manufacturer Received: 10/12/2018
• 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
• Treatment: 25-552-04-91 LEVEL ONE PLATE
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 52