MAUDE Adverse Event Report: ALPHATEC SPINE, INC INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 15100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

The implant remains in-situ.Radiograph images were provided to confirm the event.A review of the device history records were unable to be performed as the lot information of the product involved was not provided.A root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

During a postoperative visit, radiograph images revealed a set screw at s1 and one of the set screws on the closed offset connector have become loose.A revision surgery has been scheduled for (b)(6) 2023.

Manufacturer Narrative

Additional information: d4.Lot # ap00823, udi #: (b)(6).6a 11/8/2022, 6b.(b)(6) 2023.9.Yes.H3.Yes.H4.(b)(6) 2022.H6.Type of investigation: 10, 3331, investigation findings: 3243, investigation conclusion: 61.H10: two set screws returned to alphatec for evaluation.Both are pn 15100, ln ap00823.Review of the device history record indicates both set screws conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.Visual inspection of both set screws exhibit markings that are not of a typical normalized rod contact.The 1st set screws exhibits partial surface contact near the outside of the diameter.This indicates very little surface engagement with the rod.The markings on the outside of the set screw reveal it was contacting the rod on only one side as it was being inserted into the tulip.Then upon final lock down there is greater engagement on one side indicating the torque alone was not enough to fully normalize the construct on this side.The 2nd set screw exhibits markings around nearly the entire set screw, but with a mostly intact dimple in the middle of the set screw.This indicates engagement on the surface of the set screw, but the dimple feature is not as deformed as expected.The smearing wear marks are also not symmetrical between both sides.Both the 1st set screw and the normalized contact for 2nd set screw show that the dimple feature is flattened due to compression upon tightening the set screw.However, the 2nd set screw indicates that the dimple is still intact.Given that the surface wear marks are not symmetrical, and the dimple is not compressed, a proper lockdown of this set screw did not occur.The root cause was due to non-normalization of the rod to screws and set screws interface leading to the set screw disassociation.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 16436688
• MDR Text Key: 310160659
• Report Number: 2027467-2023-00011
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376137902
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K181677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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
• Device Operator: Health Professional
• Device Model Number: 15100
• Device Catalogue Number: 15100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male