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 Code Available (3191)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted set screws are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Revision surgery was conducted on (b)(6) 2018 to remove and replace the set screws located at the l2/3/4.The construct was originally implanted on (b)(6) 2018 during a posterior lumber fusion (plf) of the l2/3/4.The surgeon suspects they may have forgotten to perform the final tightening process.
Additional Manufacturer Narrative
Visual inspection under magnification found no signs that any of the 6 returned set screw had undergone the final tightening process.The bottom of the set screws which interacts with the rod does not contain any evidence of deformation or wear associated with 100 in-lbs of torque.Additionally, both the hexalobe edges and the mating threads appear crisp and clean with no associated marking/deformity caused the final torque process.The supplied instructions for use (ins-028) & surgical technique (lit-83210) provide direction as to proper set screw final tightening process.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.

• 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: 8212360
• Report Number: 2027467-2018-00087
• Device Sequence Number: 19360923
• Product Code: NKB
• UDI-Device Identifier: 00844856043688
• UDI-Public: (01)00844856043688(10)8038301
• 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,Followup
• Report Date (Section B): 12/07/2018

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: 8038301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/21/2019
• 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: Hospitalization