NA 498.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034788845), received between Jun 26, 2018 and Jun 26, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED FOR THE PATIENT WHO WAS TREATED FOR AN L1 BURST FRACTURE ON (B)(6) 2003 BY PERFORMING A T12-L2 POSTERIOR SPINAL FUSION AND PACING A SYNTHES USS HARDWARE. THE TWO (2) 6.0MM TI HARD ROD WAS BROKEN DUE TO NONUNION. ALL OTHER HARDWARE WAS INTACT. THE SURGEON REPLACED THE T12 AND L2 SCREWS. HE DID NOT REPLACE THE L1 SCREWS AS THE SURGEON PERFORMED A PEDICLE SUBTRACTION OSTEOTOMY AT THIS LEVEL TO CORRECT HYPERKYPHOSIS. THE SURGEON THEN PLACED NEW USS SCREWS AT T11 AND L3 TO EXTEND CONSTRUCT. AFTER PERFORMING THE L1 PEDICLE SUBTRACTION OSTEOTOMY (PSO). THE PROCEDURE WAS SUCCESSFUL WITH NO REPORTED SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: 6.0MM TI SIDE-OPENING SCREW 30MM (PART # 498.630, LOT # UNKNOWN, QUANTITY 1), 7.0MM TI SIDE-OPENING SCREW 50MM (PART # 498.750, LOT # UNKNOWN, QUANTITY 1), TI COLLAR WITH GROOVES (PART # 498.011, LOT # UNKNOWN, QUANTITY 1), USS NUT F/USS-VAR-AXIS-SCR USS-PEDICSCR+ (PART # 498.003, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 6.0MM TI HARD ROD 75MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7639680 ↗
• InjuryJun 26, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED FOR THE PATIENT WHO WAS TREATED FOR AN L1 BURST FRACTURE ON (B)(6) 2003 BY PERFORMING A T12-L2 POSTERIOR SPINAL FUSION AND PACING A SYNTHES USS HARDWARE. THE TWO (2) 6.0MM TI HARD ROD WAS BROKEN DUE TO NONUNION. ALL OTHER HARDWARE WAS INTACT. THE SURGEON REPLACED THE T12 AND L2 SCREWS. HE DID NOT REPLACE THE L1 SCREWS AS THE SURGEON PERFORMED A PEDICLE SUBTRACTION OSTEOTOMY AT THIS LEVEL TO CORRECT HYPERKYPHOSIS. THE SURGEON THEN PLACED NEW USS SCREWS AT T11 AND L3 TO EXTEND CONSTRUCT. AFTER PERFORMING THE L1 PEDICLE SUBTRACTION OSTEOTOMY (PSO). THE PROCEDURE WAS SUCCESSFUL WITH NO REPORTED SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: 6.0MM TI SIDE-OPENING SCREW 30MM (PART # 498.630, LOT # UNKNOWN, QUANTITY 1), 7.0MM TI SIDE-OPENING SCREW 50MM (PART # 498.750, LOT # UNKNOWN, QUANTITY 1), TI COLLAR WITH GROOVES (PART # 498.011, LOT # UNKNOWN, QUANTITY 1), USS NUT F/USS-VAR-AXIS-SCR USS-PEDICSCR+ (PART # 498.003, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 6.0MM TI HARD ROD 75MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7639655 ↗