CD HORIZON® Spinal System X0311206Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994992529), received between Jan 15, 2019 and Feb 1, 2023 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2023Break; Break

  ON (B)(6)2011 PATIENT VISITED HOSPITAL. DIAGNOSIS: RIGHT ELBOW PSORIASIFORM DERMATITIS. NOTE: THE FINDINGS ARE OF PSORIASIFORM EPIDE RMAL HYPERPLASIA, SPONGIOSIS AND ALTERNATING HYPERKERATOSIS AND PARAKERATOSIS. THESE FINDINGS ARE NOT ENTIRELY SPECIFIC BUT RAISE THE POSSIBILITY OF PITYRIASIS RUBRA PILARIS. PSORIASIS IS ALSO POSSIBLE. ON (B)(6)2012 PATIENT VISITED HOSPITAL. CHIEF COMPLAINT WAS FOLLOW-UP FOR HYPERLIPIDEMIA CHIEF, HYPERTENSION. ON (B)(6)2012 PATIENT VISITED HOSPITAL. SIGNIFICANT DIAGNOSIS: CELLULITIS ABSCESS UNSPECIFIED SITE, DIABETES MELLITUS TYPE 2 CONTROLLED, DIABETES MELLITUS TYPE 2 UNCONTROLLED W/O COMPLICATIONS, HYPERLIPIDEMIA, UNSPECIFIED, UNSPECIFIED ESSENTIAL HYPERTENSION. ON (B)(6)2012 PATIENT VISITED HOSPITAL. SIGNIFICANT DIAGNOSIS: BPH W/O OBSTRUCTION, CELLULITIS ABSCESS UNSPECIFIED SITE, DIABETES MELLITUS TYPE 2 CONTROLLED, DIABETES MELLITUS TYPE 2 UNCONTROLLED W/0 COMPLICATIONS, FATIGUE AND MALAISE, HYPERLIPIDEMIA UNSPECIFIED, ROUTINE GEN MED EXAM, UNSPECIFIED ESSENTIAL HYPERTENSION. ON (B)(6) 2012 PATIENT VISITED HOSPITAL. TESTS: AN EKG WAS PERFORMED. ON (B)(6)2013 PATIENT VISITED HOSPITAL. TESTS: AN EKG WAS PERFORMED. ON (B)(6)2014 PATIENT HAD PROSTATE

  Patient problems: Abscess; Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions; Numbness; Pain; Paresthesia; Unspecified Infection

  MAUDE report 16281662 ↗
• InjuryJan 15, 2019Break; Break

  IT WAS REPORTED THAT ON: (B)(6) 2017: PATIENT UNDERWENT X-RAY SCOLIOSIS AP AND LATERAL. IMPRESSION: RIGHT THORACIC, LEFT THORACIC, RIGHT LUMBAR, LEFT LUMBAR SCOLIOSIS WITH DYSPLASTIC CHANGES INVOLVING THE LOWER SACRUM. CROSS SECTION IMAGING OF THE SACROILIAC JOINTS AND THE SACRUM MAY BE USEFUL FOR FURTHER ASSESSMENT THE NATURE OF DYSPLASTIC CHANGES AND POSSIBLE LOWER SACRAL SPINA BIFIDA. MODERATE DIASTASES AT THE SYMPHYSIS PUBIS. SUSPECT ADVANCED CHRONIC DEGENERATIVE CHANGES AT THE LEFT SACROILIAC JOINT. (B)(6) 2017: PATIENT UNDERWENT X-RAY CHEST PORTABLE. IMPRESSION: BIBASILAR ATELECTASIS (B)(6) 2017: PATIENT UNDERWENT X-RAY SCOLIOSIS AP AND LATERAL. IMPRESSION: INTERVAL PARTIAL POSTERIOR SPINE INSTRUMENTATION FROM T10 TO BILATERAL ILIA FOLLOWING LUMBOSACRAL REGION HEMIVERTEBRA RESECTION. RESIDUAL SCOLIOSIS CURVES. PATIENT UNDERWENT X-RAY SCOLIOSIS AP AND LATERAL. IMPRESSION: T11 THROUGH ILIUM POSTERIOR SCREW AND ROD FIXATION WITH INTERVAL BILATERAL FIXATION ROD REVISION SINCE (B)(6) 2017 WITHOUT EVIDENCE OF COMPLICATION. DECREASED MAGNITUDE OF THORACOLUMBAR AND LUMBAR SCOLIOSIS. DILATED SMALL BOWEL IN THE RIGHT ABDOMEN AND PUBIC DIASTASES. UNCHANGED PERSISTING RIGHT THORACIC, LEF

  Patient problems: Pain

  MAUDE report 8247157 ↗