MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SET SCREW, HEXALOBE (TI-6AI-4V ELI); PEDICLE SCREW SYSTEM

Model Number	22015
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection under magnification found no signs that either set screw had undergone the final tightening process.Although the bottom of the set screws which interacts with the rod has a minor swoop on one side of the outer perimeter, the remainder does not contain any deformity caused by 100 in-lbs of torque.Both the hexalobe edges and the mating threads appear crisp and clean with no associated marking/deformity caused the final torque process.Both the supplied instructions for use (ins-028) and surgical technique (lit-83210) provide direction as to proper set screw final tightening process.Instruction for use ins-028; warnings: 9.It is critical that set screws are turned to the proper torque values as recommended in the surgical techniques, using the instruments provided.Intraoperative management: 6.The final operative procedure with polyaxial screws must include tightening of set screws to 100in-lb torque value with the instruments provided.Surgical technique lit-83210: assemble the 100 in-lb t-handle torque wrench with the torque wrench shaft.Insert the torque wrench assembly through the cannula of the cannulated anti-torque.Engage the male portion of the set screw driver into the female portion of the desired set screw.Slide the anti-torque down until the instrument is fully seated over the rod on each side of the screw head.Turn t-handle clockwise.Final tightening is achieved when the t-handle audibly clicks.
Event or Problem Description
The doctor found the disconnection of two set screws two weeks after the initial surgery.Re-operation was conducted on (b)(6) 2018 to replace and tighten the set screws.The illico mis posterior fixation system was originally implanted on (b)(6) 2018.

• Brand Name: SET SCREW, HEXALOBE (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: 7845746
• Report Number: 2027467-2018-00063
• Device Sequence Number: 11156558
• Product Code: NKB
• UDI-Device Identifier: 00844856043688
• UDI-Public: (01)00844856043688(10)8042902
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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: 22015
• Device Catalogue Number: 22015
• Device Lot Number: 8042902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/05/2018
• 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: Hospitalization
• Patient Age: 75 YR