EXPEDIUM 179902000Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705034084664), received between Oct 2, 2017 and Jun 12, 2025 — classified as 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (16 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD FUSION SURGERY AT T12-L1 AND A DEPUY EXPEDIUM WAS THE HARDWARE USED IN HER BACK. ON (B)(6) 2024 HER PROVIDERS REALIZED THAT THE HARDWARE HAD FAILED DUE TO "STRIPPED SCREWS" AND REVISION OF THE SURGERY HAD TO BE DONE TO T12-L1 AND TO THE NEXT LEVEL UP WHICH IS THE L1-L2, CAUSING SERIOUS INJURIES TO PATIENT. THIS COMPLAINT INVOLVES UNKNOWN NUMBER OF DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22194803 ↗
• MalfunctionJan 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE 35 MM ROD IS IN A SCREW HEAD (8X45) WITH A SET CAP OVER IT. FINAL TIGHTENER STRIPPED AND HEAD OF SCREW ENDED UP GETTING RIPPED OUT FROM SHAFT OF SCREW. PATIENT WAS NOT HARMED AT ALL. REPLACED ROD AND SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCE WAS THERE. THIS REPORT IS FOR ONE (1) EXP SINGLE-INNIE SETSCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507085 ↗
• InjuryJul 20, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY. AFTER THE PROCEDURE IT WAS NOTICED THAT THE RODS HAD DISLODGED FROM THE SCREW HEADS OF THE PELVIC SCREWS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 FOR RODS PULLING OUT OF THE SCREWS. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SINGLE INNIE SET SCREW 6.35. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17361824 ↗
• InjuryJul 20, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY. AFTER THE PROCEDURE IT WAS NOTICED THAT THE RODS HAD DISLODGED FROM THE SCREW HEADS OF THE PELVIC SCREWS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 FOR RODS PULLING OUT OF THE SCREWS. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM SINGLE INNIE SET SCREW 6.35. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17361772 ↗
• InjuryNov 2, 2022Device Slipped; Migration; Device Slipped; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (TH11 TO L4) FOR AIS ON (B)(6) 2022. AFTER THE SURGERY, THE SET SCREWS AT RIGHT L4 WERE DISLOCATED AND LOOSENED. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED. THE SET SCREWS AND THE SCREW WERE REPLACED. VISUALLY, THERE WAS NO EVIDENCE OF WIDENING OF THE SCREW HEAD OR CROSS-THREADING OF THE SET SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SINGLE INNIE SET SCREW 6.35. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15714710 ↗
• InjuryNov 2, 2022Device Slipped; Migration; Device Slipped; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (TH11 TO L4) FOR AIS ON (B)(6) 2022. AFTER THE SURGERY, THE SET SCREWS AT RIGHT L4 WERE DISLOCATED AND LOOSENED. ON OCTOBER 12, 2022, A REVISION SURGERY WAS PERFORMED. THE SET SCREWS AND THE SCREW WERE REPLACED. VISUALLY, THERE WAS NO EVIDENCE OF WIDENING OF THE SCREW HEAD OR CROSS-THREADING OF THE SET SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SINGLE INNIE SET SCREW 6.35. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15714708 ↗
• InjuryMar 12, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY DUE TO LOOSENING OF SET SCREWS. SURGEON'S PATIENT HAD PREVIOUS POSTERIOR SPINAL FUSION SURGERY. HE HAD TO DO REVISION SURGERY TODAY DUE TO LOOSENING OF THE 4 SET SCREWS. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) EXP 635 TI SI SETSCREW. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475619 ↗
• InjuryMar 12, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY DUE TO LOOSENING OF SET SCREWS. SURGEON'S PATIENT HAD PREVIOUS POSTERIOR SPINAL FUSION SURGERY. HE HAD TO DO REVISION SURGERY TODAY DUE TO LOOSENING OF THE 4 SET SCREWS. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) EXP 635 TI SI SETSCREW. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475616 ↗
• InjuryMar 12, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY DUE TO LOOSENING OF SET SCREWS. SURGEON'S PATIENT HAD PREVIOUS POSTERIOR SPINAL FUSION SURGERY. HE HAD TO DO REVISION SURGERY TODAY DUE TO LOOSENING OF THE 4 SET SCREWS. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) EXP 635 TI SI SETSCREW. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475565 ↗
• InjuryMar 12, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REMOVAL SURGERY DUE TO LOOSENING OF SET SCREWS. SURGEON'S PATIENT HAD PREVIOUS POSTERIOR SPINAL FUSION SURGERY. HE HAD TO DO REVISION SURGERY TODAY DUE TO LOOSENING OF THE 4 SET SCREWS. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREW (PART # UNKNOWN, LOT# B UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) EXP 635 TI SI SET SCREW. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475548 ↗
• MalfunctionSep 14, 2020Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A LEFT L5 LOCKING CAP BACK OUT FROM AND L4-5 FUSION WITH EXPEDIUM 6.35 BACK ON (B)(6) 2019. THE PATIENT HAS SUCCESSFULLY FUSED AND IS DOING WELL. THERE WAS NO NEED TO RETRIEVE THE CAP OR REVISE THE SURGERY. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN EXPEDIUM 6.35 (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXP 635 TI SI SETSCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530526 ↗
• InjurySep 8, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A FUSION PROCEDURE ON T11-L3. ON (B)(6) 2020, IT WAS REPORTED THAT THE SETSCREW HAD COME OFF. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2020. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: EXP 6.35 TI UNI 6 X 45MM (PART# 179988645, LOT# ARMCW2, QUANTITY 1), UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXP 635 TI SI SETSCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10503043 ↗
• InjurySep 8, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A FUSION PROCEDURE ON T11-L3. ON (B)(6) 2020, IT WAS REPORTED THAT THE SETSCREW HAD COME OFF. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2020. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: EXP 6.35 TI UNI 6 X 45MM (PART# 179988645, LOT# ARMCW2, QUANTITY 1), UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXP 635 TI SI SETSCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10503007 ↗
• InjurySep 8, 2020Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A FUSION PROCEDURE ON T11-L3. ON (B)(6) 2020, IT WAS REPORTED THAT THE SETSCREW HAD COME OFF. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2020. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: EXP 6.35 TI UNI 6 X 45MM (PART# 179988645, LOT# ARMCW2, QUANTITY 1), UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) EXP 635 TI SI SETSCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10502911 ↗
• InjuryMar 26, 2020Break; Break

  IT WAS REPORTED ON FEBRUARY 28, 2020, THE PATIENT HAD A POSTERIOR LUMBAR DECOMPRESSION AND FUSION AT L2-5 ON (B)(6) 2020. ON (B)(6) 2020, PATIENT HEARD A ¿POP¿ SOUND AND EXPERIENCED AN INCREASE IN PAIN AT THE SURGICAL SITE. IMAGING ON (B)(6) 2020 CONFIRMED THAT THE LOCKING CAP OF THE LEFT L2 SCREW HAD DISENGAGED FROM THE TULIP OF THE PEDICLE SCREW. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. DURING THE REVISION PROCEDURE, THE 4 LOCKING CAPS AND ROD ON THE LEFT WERE REMOVED AND REPLACED WITH A NEW ROD AND 4 NEW LOCKING CAPS. THE LOCKING CAPS ON THE RIGHT SIDE WERE RE-TORQUED TO CONFIRM THEY WERE APPROPRIATELY LOCKED. THE WOUND WAS WASHED AND THEN CLOSED. PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: ROD, STR, TI, 450MM (HX END) (PART # 179963450 , LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) EXP 635 TI SI SETSCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9883883 ↗
• InjuryMar 26, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT HAD A POSTERIOR LUMBAR DECOMPRESSION AND FUSION AT L2-5 ON (B)(6) 2020. ON (B)(6) 2020, PATIENT HEARD A ¿POP¿ SOUND AND EXPERIENCED AN INCREASE IN PAIN AT THE SURGICAL SITE. IMAGING ON (B)(6) 2020 CONFIRMED THAT THE LOCKING CAP OF THE LEFT L2 SCREW HAD DISENGAGED FROM THE TULIP OF THE PEDICLE SCREW. REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. DURING THE REVISION PROCEDURE, THE 4 LOCKING CAPS AND ROD ON THE LEFT WERE REMOVED AND REPLACED WITH A NEW ROD AND 4 NEW LOCKING CAPS. THE LOCKING CAPS ON THE RIGHT SIDE WERE RE-TORQUED TO CONFIRM THEY WERE APPROPRIATELY LOCKED. THE WOUND WAS WASHED AND THEN CLOSED. PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: ROD, STR, TI, 450MM (HX END) (PART # 179963450 , LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) EXP 635 TI SI SETSCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9883882 ↗
• InjuryAug 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT SIDE L4, L5, S1, AND LATERAL CONNECTOR LOCKING CAP POPPED OFF AND WERE REPLACED WITH S1 SCREW WITH LARGER DIAMETER SCREW AND NEW LOCKING CAPS. ON (B)(6) 2017, THE PATIENT HAD T5-PELVIS FUSION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8921853 ↗
• InjuryAug 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2109, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT SIDE L4, L5, S1, AND LATERAL CONNECTOR LOCKING CAP POPPED OFF AND WERE REPLACED WITH S1 SCREW WITH LARGER DIAMETER SCREW AND NEW LOCKING CAPS. ON (B)(6) 2017, THE PATIENT HAD T5-PELVIS FUSION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8921709 ↗
• InjuryAug 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) "2109", THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT SIDE L4, L5, S1, AND LATERAL CONNECTOR LOCKING CAP POPPED OFF AND WERE REPLACED WITH S1 SCREW WITH LARGER DIAMETER SCREW AND NEW LOCKING CAPS. ON (B)(6) 2017, THE PATIENT HAD T5-PELVIS FUSION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8920959 ↗
• InjuryAug 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT SIDE L4, L5, S1, AND LATERAL CONNECTOR LOCKING CAP POPPED OFF AND WERE REPLACED WITH S1 SCREW WITH LARGER DIAMETER SCREW AND NEW LOCKING CAPS. ON (B)(6) 2017, THE PATIENT HAD T5-PELVIS FUSION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8920905 ↗
• InjurySep 5, 2018Migration; Migration

  IT WAS REPORTED DURING REVIEW OF FOLLOW UP XRAYS, FOUR SET SCREWS WERE FOUND BACKED OUT FROM L4-ILIUM. REVISION SURGERY SCHEDULED FOR (B)(6) 2018.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7845783 ↗
• InjurySep 5, 2018Migration; Migration

  IT WAS REPORTED DURING REVIEW OF FOLLOW UP XRAYS, FOUR SET SCREWS WERE FOUND BACKED OUT FROM L4-ILIUM. REVISION SURGERY SCHEDULED FOR (B)(6) 2018

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7845760 ↗
• InjurySep 5, 2018Migration; Migration

  IT WAS REPORTED DURING REVIEW OF FOLLOW UP XRAYS, FOUR SET SCREWS WERE FOUND BACKED OUT FROM L4-ILIUM. REVISION SURGERY SCHEDULED FOR (B)(6) 2018.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7845711 ↗
• InjurySep 5, 2018Migration; Migration

  IT WAS REPORTED DURING REVIEW OF FOLLOW UP XRAYS, FOUR SET SCREWS WERE FOUND BACKED OUT FROM L4-ILIUM. REVISION SURGERY SCHEDULED FOR (B)(6) 2018

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7845655 ↗
• InjuryJan 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED VIA VOICEMAIL, THERE WAS AN ISSUE WITH 2 SET SCREWS, 1799-02-000. ADDITIONAL INFORMATION FROM SUBMITTED COMPLAINT FORM FROM SALES REP. PATIENT NOTICED A CHANGE IN FEELING IN HIS BACK. UPON, X-RAY, IT WAS NOTICED THAT THE SET SCREWS IN THE ILIAC BOLTS AN S1 SCREWS HAD LOOSENED AND CAME OFF.

  Patient problems: Spinal Column Injury

  MAUDE report 7179294 ↗