LANCER™/ THUNDERBOLT™ Pedicle Screw System MT20-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840996110891), received between Sep 26, 2023 and Sep 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2023Migration; Migration

  DR. (B)(6) RELAYED THAT 1 OF HIS PATIENTS ((B)(6)) EXPERIENCED POSTOPERATIVE ROD/SETSCREW/PEDICLE SCREW INTERFACE ISSUES TWICE. THE ISSUES CONSISTED OF RODS EITHER PARTIALLY SLIPPING OUT OF OR BECOMING DISASSOCIATED WITH THE TULIPS OF PEDICLE SCREWS, POSTOPERATIVELY. AFTER THE INITIAL POSTERIOR DECOMPRESSION AND PEDICLE SCREW STABILIZATION FROM T10 TO THE PELVIS PROCEDURE (DOS: (B)(6) 2022), THE PATIENT RETURNED FOR A FOLLOW-UP POSTOPERATIVE VISIT. X-RAY IMAGES REVEALED THAT THE RODS HAD SLIPPED OUT OF THE PELVIC SCREW TULIPS. TO ADDRESS THIS ISSUE, DR. (B)(6) REVISED THE PATIENT ON (B)(6) 2022. THE REVISION CASE CONSISTED OF ADDING 2 PELVIC SCREWS, 2 DOMINO ROD-TO-ROD CONNECTORS, 2 COBALT CHROME RODS (TO CREATE A 4-ROD STABILIZATION CONSTRUCT), AND REPLACING ALL THE SET SCREWS. THE PATIENT RETURNED FOR A POSTOPERATIVE FOLLOW-UP VISIT AT WHICH TIME DR. (B)(6) DISCOVERED, THROUGH X-RAY IMAGES, THAT AT LEAST 2 OF THE RODS HAD SLIPPED OUT OF AT LEAST 2 OF THE PELVIS SCREW TULIPS.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 17816186 ↗