Reform TI Pedicle Screw System 39-SB-6545Recalls & reported problems
Precision Spine, Inc. · Modular Bone Screw, 6.5mm x 45mm, Green · Class 2 · Implant
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 00840019931953), received between Jun 2, 2023 and Jun 2, 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.
InjuryJun 2, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT TLIF L5-S1 TO ADDRESS DEGENERATIVE DISC DISEASE ON (B)(6) 2022. SUBSEQUENTLY, DURING ROUTINE FOLLOW-UP IT WAS NOTED THAT ONE Ø6.5MM X 45MM REFORM TI MODULAR NON-CANNULATED SCREW (39-SB-6545) AND ONE Ø6.5MM X 50MM REFORM TI MODULAR NON-CANNULATED SCREW (39-SB-6550) HAD BROKEN. AN ALIF L5-S1 REVISION WAS PERFORMED ON (B)(6) 2022, DURING WHICH THE BROKEN SCREWS WERE PARTIALLY REMOVED (DISTAL PORTION OF SHANK WAS INACCESSIBLE) FROM S1 WITH ANOTHER SCREW PLACED. THE PATIENT INDICATES NO TRAUMA OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052840 ↗InjuryJun 2, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT TLIF L5-S1 TO ADDRESS DEGENERATIVE DISC DISEASE ON (B)(6) 2022. SUBSEQUENTLY, DURING ROUTINE FOLLOW-UP IT WAS NOTED THAT ONE Ø6.5MM X 45MM REFORM TI MODULAR NON-CANNULATED SCREW (39-SB-6545) AND ONE Ø6.5MM X 50MM REFORM TI MODULAR NON-CANNULATED SCREW (39-SB-6550) HAD BROKEN. AN ALIF L5-S1 REVISION WAS PERFORMED ON (B)(6) 2022, DURING WHICH THE BROKEN SCREWS WERE PARTIALLY REMOVED (DISTAL PORTION OF SHANK WAS INACCESSIBLE) FROM S1 WITH ANOTHER SCREW PLACED. THE PATIENT INDICATES NO TRAUMA OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052836 ↗
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- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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