MAUDE Adverse Event Report: GENESYS SPINE TILOCK PEDICLE SCREW SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reached out to genesys spine to report that two (2) nitinol guidewires had broken during an mis procedure.The complainant reported that the patient had "very, very hard and dense bone" but the surgeon did not note any other unusual occurence until he tried to remove the wires after screw placement.At this point the wires felt "stuck" and were difficult to remove.The surgeon had to attach instrumentation to the wires to pull hard enough to remove them from the screws however, in doing so, broke off the tips of the wires.

• Brand Name: TILOCK PEDICLE SCREW SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of texas hwy; building 3, suite 600; austin TX 78746
• MDR Report Key: 9256708
• Report Number: 3008455034-2019-00010
• Device Sequence Number: 16614226
• Product Code: MNI
• UDI-Device Identifier: M719GLC124S0
• UDI-Public: +M719GLC124S0/$$7AN201805150
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: 1
• Device Catalogue Number: GLC124-S
• Device Lot Number: AN20180515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/30/2019
• 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: Required Intervention