Reform Pedicle Screw System 39-SC-5500Recalls & reported problems
Precision Spine, Inc. · ø5.5 x 500mm Hex-End Rod (CoCr) · Class 2 · Implant
All models of Reform Pedicle Screw System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019901703), received between Sep 27, 2023 and Sep 27, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED APPROXIMATELY ONE YEAR AGO. SUBSEQUENTLY, PATIENT PRESENTED WITH PAIN AND A REVISION WAS PERFORMED IN (B)(6) 2023 TO ADDRESS BROKEN RODS ON A THIRTEEN LEVEL CONSTRUCT. THERE WAS NO REPORT OF TRAUMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17827967 ↗InjurySep 27, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED APPROXIMATELY ONE YEAR AGO. SUBSEQUENTLY, PATIENT PRESENTED WITH PAIN AND A REVISION WAS PERFORMED IN (B)(6) 2023 TO ADDRESS BROKEN RODS ON A THIRTEEN LEVEL CONSTRUCT. THERE WAS NO REPORT OF TRAUMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17827941 ↗
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- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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