TIGER Spine System 55065-40Recalls & reported problems
Corelink LLC · 5500 SERIES PEDICLE SCREW 6.5MM X 40MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M72555065400), received between Sep 24, 2015 and Sep 24, 2015 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Code Available1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2015Break
(B) THE DISTRIBUTOR CALLED, IDENTIFYING THAT A REVISION SURGERY WAS COMPLETED ON (B)(6) 2015 TO REMOVE A 55065-40 (6.5MM X 40MM) PEDICLE SCREW FROM THE PATIENTS S1. THE DISTRIBUTOR IDENTIFIED THAT THE SCREW HAD BROKEN AT THE NECK OF THE SCREW BODY AND WAS REMOVED DURING A REVISION SURGERY. THE SCREWS WERE INITIALLY IMPLANTED ON (B)(6) 2013, THE DISTRIBUTOR WAS MADE AWARE OF THE REVISION SURGERY TO OCCUR ON (B)(6) 2015 AND CORELINK (THE MANUFACTURER) WAS MADE AWARE ON (B)(4) 2015. IT WAS IDENTIFIED BY THE PHYSICIAN TO THE DISTRIBUTOR THAT NO BONY FUSION HAD OCCURRED AT THE TIME THE BROKEN SCREW WAS EXPLANTED. (THIS REPORT IS FOR THE 2ND OF 2 SCREWS IDENTIFIED IN THIS SCENARIO).
Patient problems: No Information
MAUDE report 5102333 ↗MalfunctionSep 24, 2015Break
THE DISTRIBUTOR CALLED, IDENTIFYING THAT A REVISION SURGERY WAS COMPLETED ON (B)(6), 2015 TO REMOVE A 55065-40 (6.5MM X 40MM) PEDICLE SCREW FROM THE PATIENTS S1. THE DISTRIBUTOR IDENTIFIED THAT THE SCREW HAD BROKEN AT THE NECK OF THE SCREW BODY AND WAS REMOVED DURING A REVISION SURGERY. THE SCREWS WERE INITIALLY IMPLANTED ON (B)(6), 2013, THE DISTRIBUTOR WAS MADE AWARE OF THE REVISION SURGERY TO OCCUR ON (B)(6), 2015 AND CORELINK (THE MANUFACTURER) WAS MADE AWARE ON AUGUST 19, 2015. IT WAS IDENTIFIED BY THE PHYSICIAN TO THE DISTRIBUTOR THAT NO BONY FUSION HAD OCCURRED AT THE TIME THE BROKEN SCREW WAS EXPLANTED. (THIS REPORT IS FOR 1 OF 2 SCREWS IDENTIFIED IN THIS SCENARIO)
Patient problems: No Code Available
MAUDE report 5102317 ↗
Other Appliance, Fixation, Spinal Interlaminal devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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