MAUDE Adverse Event Report: GENESYS SPINE LUMBAR PLATE HELIOS DRIVER; LUMBAR PLATE SCREW DRIVER

Model Number	GLP159
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a binary lumbar plate procedure the tip of the threaded inner shaft of the lumbar plate driver broke off (separated) in the head of a lumbar plate screw.The representative covering the case stated there were no abnormalities during insertion of the screw and nothing extraordinary occurred prior to the instrument failure.The broken portion of the instrument could not be retrieved from the screw and was subsequently implanted in the patient.

• Brand Name: LUMBAR PLATE HELIOS DRIVER
• Common Device Name: LUMBAR PLATE SCREW DRIVER
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx hwy; building 3, suite 600; austin TX 78746
• Manufacturer Contact: chloe lance ; 1250 s. capital of tx hwy; building 3, suite 600; austin, TX 78746 ; 5123817089
• MDR Report Key: 13620342
• Report Number: 3008455034-2022-00002
• Device Sequence Number: 14907413
• Product Code: KWQ
• UDI-Device Identifier: M719GLP1590
• UDI-Public: +M719GLP1590/$$7LK20200831A5
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLP159
• Device Lot Number: LK20200831A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown