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

Model Number	25-975-05-91
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Screws were removed in order to reposition the plates.14 screws were implanted and all needed to be removed.On removal two broke at the head.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics and data analysis as no device was sent back for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.The device lot number was not provided by the customer therefore the device history records could not be reviewed.Due to no device being returned the root cause for the failure cannot be determined.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 NEURO
• Common Device Name: SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6335606
• Report Number: 9610905-2017-00008
• Device Sequence Number: 11154179
• Product Code: HRS
• UDI-Device Identifier: 00888118048790
• UDI-Public: (01)00888118048790
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

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
• Operator of Device: Physician
• Device Model Number: 25-975-05-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR