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

Model Number	24-023-15-91
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient mentioned to the doctor a few days post-op regarding a popping sound from the implant site along his coughing fit.The surgeon discovered one of the screws that were stabilizing the plate was displaced.The surgeon replaced the implants.This is one of three incidents.Please refer mdr 9610509-2016-00027 and mdr 9610509-2016-00028.
Additional Manufacturer Narrative
Methods: visual inspection, stereo microscopic inspection, and performance test on a standard sample plate results: the devices were optically assessed and stereo microscopically investigated in the lab.The stereo microscopic investigation revealed surface damage but no breakage.Further observation determined there were no indications of material or manufacturing defects discovered.The developer tested the function and there was no abnormality found.The device history records could not be reviewed since no lot number was provided by the reporter.Assessment conclusion: the results of the investigation could not determine the root cause of loosening of the screw.If further information can be gathered that might add value to the contents of the investigated report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE THORACIC SCREW
• Common Device Name: BONE SCREW
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 5791769
• Report Number: 9610905-2016-00026
• Device Sequence Number: 19208334
• Product Code: HRS
• UDI-Device Identifier: 00888118031662
• UDI-Public: (01)00888118031662
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2016

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: Health Professional
• Device Model Number: 24-023-15-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 08/19/2016
• 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