Malibu™ 12-1070Recalls & reported problems
Seaspine Orthopedics Corporation · PRECONTOURED ROD, 5.5 x 70mm · Class 2 · Implant
Data updated Oct 13, 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 10889981029982), received between Jul 12, 2019 and Jul 12, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- Failure of Implant2
- Patient Problem/Medical Problem2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
INDEX SURGERY OCCURRED ON (B)(6) 2017, WHICH INCLUDED A PARTIAL L4-5 DECOMPRESSIVE LUMBAR LAMINECTOMY, LEFT L5-S1 MICROFORAMINOTOMY, L4 TO S1 PEDICLE INSTRUMENTATION AND FACET FUSION. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, BILATERAL SET SCREWS WERE BROKEN, AND RODS WERE BENT. IT IS UNKNOWN HOW THE DISCOVERY OF BROKEN SET SCREWS AND BENT RODS WERE IDENTIFIED, AS NO IMAGES OR MEDICAL EVALUATION WERE PROVIDED. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, THE PATIENT SUSTAINED INJURIES WHICH RESULTED IN PAIN, REQUIRING SURGICAL INTERVENTION. REVISION OCCURRED ON (B)(6) 2018, WHICH INCLUDED REMOVAL OF MANUFACTURER'S FIXATION SYSTEM. CURRENT PATIENT CONDITION IS UNKNOWN.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 8786032 ↗InjuryJul 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
INDEX SURGERY OCCURRED ON (B)(6) 2017, WHICH INCLUDED A PARTIAL L4-5 DECOMPRESSIVE LUMBAR LAMINECTOMY, LEFT L5-S1 MICROFORAMINOTOMY, L4 TO S1 PEDICLE INSTRUMENTATION AND FACET FUSION. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, BILATERAL SET SCREWS WERE BROKEN, AND RODS WERE BENT. IT IS UNKNOWN HOW THE DISCOVERY OF BROKEN SET SCREWS AND BENT RODS WERE IDENTIFIED, AS NO IMAGES OR MEDICAL EVALUATION WERE PROVIDED. ACCORDING TO THE LEGAL DOCUMENT RECEIVED, THE PATIENT SUSTAINED INJURIES WHICH RESULTED IN PAIN, REQUIRING SURGICAL INTERVENTION. REVISION OCCURRED ON (B)(6) 2018, WHICH INCLUDED REMOVAL OF MANUFACTURER'S FIXATION SYSTEM. CURRENT PATIENT CONDITION IS UNKNOWN.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 8786031 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
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- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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