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

Model Number 99-576-76-05

Device Problem Osseointegration Problem (3003)

Patient Problem Impaired Healing (2378)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reference exemption number e2017029.An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The failure root cause cannot be determined due to the device not being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

Event Description

It was reported screws pulled from the bone and became loose.Screws were removed.

Manufacturer Narrative

Added codes.

• Brand Name: LEVEL ONE NEURO
• Type of Device: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 10884241
• MDR Text Key: 217639930
• Report Number: 9610905-2020-00129
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00888118101068
• UDI-Public: (01)00888118101068
• Combination Product (y/n): N
• PMA/PMN Number: K944565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 99-576-76-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR