SPIRA™ Open Matrix ALIF SPA-2632-0815Recalls & reported problems
Camber Spine Technologies, LLC · Bi-Convex 8° Lordotic, 26mm x 32mm, 15mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B030SPA263208150), received between Jul 13, 2023 and Jul 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
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
- Patient Device Interaction Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT WENT UNDER A L5/S1 ALIF SURGERY ON (B)(6) 2023. DURING THIS PROCEDURE, THE PATIENT WAS IMPLANTED WITH A (B)(6) CAGE PACKED WITH INFILL CBM INTO THE PATIENT'S L5/S1 DISC SPACE, POST-DISCECTOMY. THE SURGEON UTILIZED ORTHOFIX'S UNITY ANTERIOR LUMBAR PLATING SYSTEM FOR SUPPLEMENTAL FIXATION, WHERE HE IMPLANTED AN ANTERIOR SACRAL PLATE SECURED WITH TWO DIVERGENT SCREWS INTO L5 AND TWO CONVERGENT SCREWS INTO S1. THERE WERE NO CONSPICUOUS INTRA-OPERATIVE COMPLICATIONS OTHER THAN A REDIRECTION OF INITIAL TRAJECTORY FOR ONE SACRAL SCREW. THE PATIENT LEFT THE FACILITY WITHIN 24 HOURS. TWO WEEKS POST-OP, THE PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN. X-RAY & CT IMAGING REVEALED NOTABLE BACK-OUT AND ANTERIOR MIGRATION OF ALL HARDWARE (PLATE/SCREW CONSTRUCT AND CAGE) AS WELL AS BONE FRACTURES INCLUDING AN L5 CORONAL FRACTURE THROUGH THE BODY'S ENTIRETY AND A TRANSVERSE S1 FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE SURGEON REMOVED ALL THE IMPLANTS (PLATES, SCREWS AND CAGE). THE EXPLANTED CAGE (B)(6) SHOWED NO VISIBLE SIGNS OF DAMAGE/DEFECT. THE SURGEON IMPLANTED ALPHAETEC'S IDENTI-TI STANDALONE ALIF CAGE AND SECURED IT USING THE ORTHROS MIS SCREWS AT L5 AND S1 P
Patient problems: Bone Fracture(s)
MAUDE report 17316304 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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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