EXPEDIUM VERSE 199723860SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034444291), received between Apr 28, 2021 and Apr 28, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS FOUND THAT THE SCREWS WHICH WERE DEPLOYED IN THE RIGHT ILIUM HAD COME OFF THE ROD. HE UNDERWENT FOR A REVISION SURGERY FOR ROD FUSION, AND IT WAS CONFIRMED THAT REMAINING SCREWS HAD NOT BEEN LOOSE. THE PLF REVISION PROCEDURE WAS PERFORMED TO EXTEND THE FUSION RANGE UP THE ILIUM ON JAN 18, 2021. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN ROD HOLDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001S, LOT# XP1233, QUANTITY 1). SINGLE-INNER SETSCREW (PART# 179702000, LOT# 286895, QUANTITY 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 8.0X60. THIS REPORT IS 1 OF 3 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11740467 ↗
• InjuryApr 28, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS FOUND THAT THE SCREWS WHICH WERE DEPLOYED IN THE RIGHT ILIUM HAD COME OFF THE ROD. HE UNDERWENT FOR A REVISION SURGERY FOR ROD FUSION, AND IT WAS CONFIRMED THAT REMAINING SCREWS HAD NOT BEEN LOOSE. THE PLF REVISION PROCEDURE WAS PERFORMED TO EXTEND THE FUSION RANGE UP THE ILIUM ON (B)(6) 2021. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TIGHTENER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN ROD HOLDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). 5.5 EXP VERSE UNITIZED SET SCR (PART# 199721001S, LOT# XP1233, QUANTITY 1). SINGLE-INNER SETSCREW (PART# 179702000, LOT# 286895, QUANTITY 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 8.0X60. THIS REPORT IS 2 OF 3 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11740457 ↗
• InjuryApr 28, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS FOUND THAT THE SCREWS WHICH WERE DEPLOYED IN THE RIGHT ILIUM HAD COME OFF THE ROD. HE UNDERWENT FOR A REVISION SURGERY FOR ROD FUSION, AND IT WAS CONFIRMED THAT REMAINING SCREWS HAD NOT BEEN LOOSE. THE PLF REVISION PROCEDURE WAS PERFORMED TO EXTEND THE FUSION RANGE UP THE ILIUM ON (B)(6) 2021. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SET SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN TIGHTENER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN ROD HOLDER (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE UNITIZED SET SCR (PART # 199721001S, LOT # XP1233, QUANTITY 1), SINGLE-INNER SET SCREW (PART # 179702000, LOT # 286895, QUANTITY 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.5 EXP VERSE FEN SCR 8.0 X 60. THIS REPORT IS 3 OF 3 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11740288 ↗