Xspan Laminoplasty Fixation System X085-0250-STRRecalls & reported problems
Xtant Medical Holdings, Inc. · HINGE PLATE, LAMINOPLASTY, SIDE-BY-SIDE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M697X0850250STR1), received between Feb 2, 2022 and Feb 2, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (6 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
- Expiration Date Error6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2022Expiration Date Error; Expiration Date Error
THE MANUFACTURER RECEIVED NOTIFICATION ON (B)(6) 2022 OF NINE IMPLANTS THAT WERE IMPLANTED PAST EXPIRATION DURING A LAMINOPLASTY PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00003, 3005031160-2022-00004, 3005031160-2022-00005, 3005031160-2022-00006, 3005031160-2022-00007, 3005031160-2022-00008, 3005031160-2022-00009, AND 3005031160-2022-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13428122 ↗MalfunctionFeb 2, 2022Expiration Date Error; Expiration Date Error
THE MANUFACTURER RECEIVED NOTIFICATION ON 1/04/2022 OF NINE IMPLANTS THAT WERE IMPLANTED PAST EXPIRATION DURING A LAMINOPLASTY PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00003, 3005031160-2022-00004, 3005031160-2022-00005, 3005031160-2022-00006, 3005031160-2022-00007, 3005031160-2022-00008, 3005031160-2022-00010, AND 3005031160-2022-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13428088 ↗MalfunctionFeb 2, 2022Expiration Date Error; Expiration Date Error
THE MANUFACTURER RECEIVED NOTIFICATION ON 1/04/2022 OF NINE IMPLANTS THAT WERE IMPLANTED PAST EXPIRATION DURING A LAMINOPLASTY PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00003, 3005031160-2022-00004, 3005031160-2022-00005, 3005031160-2022-00006, 3005031160-2022-00007, 3005031160-2022-00008, 3005031160-2022-00009, AND 3005031160-2022-00010.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13428035 ↗MalfunctionFeb 2, 2022Expiration Date Error; Expiration Date Error
THE MANUFACTURER RECEIVED NOTIFICATION ON (B)(6) 2022 OF NINE IMPLANTS THAT WERE IMPLANTED PAST EXPIRATION DURING A LAMINOPLASTY PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00003, 3005031160-2022-00004, 3005031160-2022-00005, 3005031160-2022-00007, 3005031160-2022-00008, 3005031160-2022-00009, 3005031160-2022-00010, AND 3005031160-2022-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13427985 ↗MalfunctionFeb 2, 2022Expiration Date Error; Expiration Date Error
THE MANUFACTURER RECEIVED NOTIFICATION ON 1/04/2022 OF NINE IMPLANTS THAT WERE IMPLANTED PAST EXPIRATION DURING A LAMINOPLASTY PROCEDURE ON (B)(6)2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00003, 3005031160-2022-00004, 3005031160-2022-00005, 3005031160-2022-00006, 3005031160-2022-00007, 3005031160-2022-00009, 3005031160-2022-00010, AND 3005031160-2022-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13427974 ↗MalfunctionFeb 2, 2022Expiration Date Error; Expiration Date Error
THE MANUFACTURER RECEIVED NOTIFICATION ON 1/04/2022 OF NINE IMPLANTS THAT WERE IMPLANTED PAST EXPIRATION DURING A LAMINOPLASTY PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED WITH 3005031160-2022-00003, 3005031160-2022-00004, 3005031160-2022-00005, 3005031160-2022-00006, 3005031160-2022-00008, 3005031160-2022-00009, 3005031160-2022-00010, AND 3005031160-2022-00011.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13427944 ↗
Other ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL devices
- Centerpiece Plate Fixation System 8532065Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL13 reports
- Centerpiece Plate Fixation System 8532067Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL11 reports
- Xspan Laminoplasty Fixation System X085-0150-STRXtant Medical Holdings, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL3 reports
- Centerpiece Plate Fixation System G8532067Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL3 reports
- ESCALATE 48570300Stryker Corporation · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL2 reports
- CANOPY 1102.1005Globus Medical, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL1 report
- CANOPY 1102.4011Globus Medical, Inc. · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL1 report
- Gallery™ Laminoplasty System 14-523101Biomet Spine LLC · ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL1 report
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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