EXPEDIUM VERSE 199721540Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705034442457), received between Nov 12, 2019 and Sep 29, 2022 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 14 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15505777 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 13 OF 14 FOR (B)(4) ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15505720 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 12 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15505662 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 11 OF 14 (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15505587 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 10 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15505360 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 9 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15504796 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 8 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15504581 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 7 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15504387 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 6 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15503861 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 5 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15503731 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 4 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15503681 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 2 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501710 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 1 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501535 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. SURGICAL CLEANING WAS PERFORMED; NO DEVICES WERE EXPLANTED. PATIENT WAS ORIGINALLY TREATED WITH THE EXPEDIUM VERSE SYSTEM ON (B)(6) 2022. THIS REPORT IS FOR A 5.5 EXP VERSE SCREW 5.0 X 40. THIS IS REPORT 3 OF 14 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501521 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 2 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501422 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 3 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501382 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 4 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501257 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THE PATIENT EXPERIENCED A POST-OPERATIVE INFECTION. THIS IS REPORT 1 OF 13 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15501230 ↗
• MalfunctionSep 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE EXPEDIUM VERSE SCREW LOCKED AND COULD NOT BE OPENED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 5.0 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446478 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9315846 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9315817 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9314864 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9314832 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT T2-T12 INSTRUMENTED FUSION FOR IDIOPATHIC SCOLIOSIS. THE FOLLOWING SCREWS, RODS AND HOOKS WERE PLACED: LEFT SIDE: T2 LAMINAR 8MM WIDE BLADE HOOK, T3 4.35 X 35 VERSE, T4 5.0 X 35 VERSE, T5 SKIP, T6 5.0 X 40 VERSE, T7 SKIP, T8 5.0 X 40 VERSE, T9 5.0 X 40 VERSE, T10 5.0 X 40 VERSE, T11 6.0 X 40 AND T12 6.0 X 40. RIGHT SIDE: T2 PEDICLE UP GOING HOOK EXPEDIUM, T3 SKIP, T4 PEDICLE UP GOING HOOK EXPEDIUM, T5 4.35 X 35 VERSE, T6 SKIP, T7 5.0 X 35 VERSE, T8 SKIP, T9 6.0 X 40 VERSE, T10 SKIP, T11 6.0 X 40 VERSE AND T12 6.0 X 40 VERSE. TWO 5.5 X 480 COCR RODS WERE CUT AND PLACED WITH CORRECTION KEYS AND REGULAR LOCKING CAPS FOR HOOKS. CORRECTION KEYS WERE LOCKED ON THE CONCAVE SIDE TO CREATE MONO SCREWS ON THE LEFT SIDE. UPON REMOVING THE RIGHT SIDE, THE PATIENT LOST SSEP¿S (SOMATOSENSORY EVOKED POTENTIAL) AND MOTORS TO LOWER EXTREMITIES. ALL THE RODS WERE REMOVED. SIGNALS DID NOT COME BACK. WAKE UP TEST PERFORMED AND SLIGHT MOVEMENT OF LOWER EXTREMITY BUT MARGINAL. IMAGES WERE TAKEN TO CONFIRM ACCURATE SCREW PLACEMENT AND ALL SCREWS LOCKED WELL PLACED. ALL SCREWS WERE REMOVED, AND PEDICLES WERE STIMULATED WITH A PROBE. NO RESPONSES WERE

  Patient problems: Spinal Cord Injury

  MAUDE report 9310867 ↗