CD HORIZON® Fenestrated Screw Set 55840027545TRecalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS 55840027545T 5.5/6.0 FENSTRTD 7.5X45 · Class 2 · Implant
All models of CD HORIZON Fenestrated Screw Set (27)
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 00643169678941), received between Jun 18, 2025 and Jun 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), STUDY ID (B)(6) AND SUB-EVENT NUMBER: 5. DESCRIPTION: PSEUDOARTHROSIS W/ HALO AROUND S1 SCREWS LONG DESCRIPTION: PSEUDOARTHROSIS W/ HALO AROUND S1 SCREWS ONSET DATE: 2022-07-25. OUTCOME STATUS: PENDING INTERVENTIONS: ACTION SUBTYPE: OTHER ACTION RESULT: YES- OBSERVATION ONLY ACTION SUBTYPE: OTHER RELEVANT ACTIONS ACTION RESULT: YES, SITE SERIOUSNESS ASSESSMENT: THERE IS NO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, LIFE THREATENING AND MEDICAL INTERVENTION, BUT THE SEVERITY OF ADVERSE EVENT IS MODERATE. SITE RELATED ASSESSMENT: NOT RELATED TO INTERBODY FUSION, PLF GRAFTING MATERIAL, POSTERIOR FIXATION, SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE OR SURGICAL PROCEDURE. DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: L-SPINE IMAGES-1 ACTION RESULT: ABNORMAL ACTION DATE: (B)(6) 2022 ACTION INFO: DIAGNOSTIC TESTS PERFORMED: PSEUDOARTHROSIS W/ HALO AROUND S1 SCREWS ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: L-SPINE IMAGES-2 ACTION RESULT: ABNORMAL ACTION DATE: (B)(6) 2022 ACTION INFO: DIAGNOSTIC TESTS PERFORMED: UNCHANGED SINCE IMAGES ON (B)(6) 2022 RAN
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 22260533 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page