MAUDE Adverse Event Report: ALPHATEC SPINE, INC. TI CANNULATED POLYAXIAL SCREW 7.5 MM X 50 MM (TI-6AI-4V ELI); PEDICLE SCREW SYSTEM

Model Number	73875-50
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information provided by the international customer indicated they believe the event was due to a bad connection between the instrument & polyaxial screw.Visual inspection appears to confirm this report.An evaluation of the returned polyaxial screw found one side of the tulip has been completely broken/detached from the remainder of the implant.Additionally, both the set screw & polyaxial screw appear to have gouges and markings indicative of cross threading.It appears likely that the anti-torque may not have been completely seated and when forces were placed on the screw during the final tightening process.
Event or Problem Description
An international customer ((b)(6)) reported that the cannulated screw located at the iliac broke during the final tightening process.The screw was removed and replaced without issue.

• Brand Name: TI CANNULATED POLYAXIAL SCREW 7.5 MM X 50 MM (TI-6AI-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 7637592
• Report Number: 2027467-2018-00043
• Device Sequence Number: 1818463
• Product Code: NKB
• UDI-Device Identifier: 00844856043367
• UDI-Public: (01)00844856043367(10)687251
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: Physician
• Device Model Number: 73875-50
• Device Catalogue Number: 73875-50
• Device Lot Number: 687251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR