Affix 7577045Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887517062352), received between Oct 25, 2017 and Nov 8, 2017 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L4-5 LEVELS. AN INDEPENDENT RADIOGRAPHIC REVIEWER REPORTED A 12 MONTH FILM INDICATED SUPERIOR L4 SPINOUS PROCESS FRACTURE. NO INDICATION OF REVISION PROCEDURE WAS REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7010508 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L4-5 LEVELS. A THIRD PARTY 12 MONTH POST-OPERATIVE RADIOGRAPHIC FILM REPORTED A SUPERIOR L4 SPINOUS PROCESS FRACTURE. IT WAS REPORTED THE PATIENT HAD NO NEUROLOGIC SYMPTOMS THROUGHOUT THE POSTOPERATIVE COURSE AND WAS NEUROLOGICALLY INTACT, PATIENT HAD SUCCESSFUL FUSION.

  Patient problems: No Code Available

  MAUDE report 6994273 ↗
• MalfunctionNov 1, 2017Unintended Movement; Unintended Movement

  ON (B)(6) 2010, A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L2-3 LEVELS. AT THE THREE MONTH POST-OPERATIVE VISIT, RADIOGRAPH OBSERVATION INDICATED THE AFFIX PLATE WAS OFF CENTER. NO TREATMENT OR REVISION PROCEDURE WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6993187 ↗
• InjuryOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011 A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L4-5 LEVELS. SIX WEEKS POST INDEX SURGERY PATIENT WAS DIAGNOSED WITH SUPERFICIAL WOUND INFECTION AND SEROMA. PATIENT WAS HOSPITALIZED FOR WOUND DRAINAGE AND TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 6985301 ↗
• MalfunctionOct 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2011, A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L4-5 LEVELS. AT THE 12-MONTH EVALUATION PLATE MIGRATION WAS OBSERVED. NO REVISION PROCEDURE WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6983096 ↗
• InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L4-5 LEVELS. ON (B)(6) 2011, THE PATIENT WAS TREATED FOR A SUPERFICIAL WOUND INFECTION. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE OF THE WOUND.

  Patient problems: Unspecified Infection

  MAUDE report 6980097 ↗
• MalfunctionOct 26, 2017Unstable; Unintended Movement; Unstable; Unintended Movement

  ON (B)(6) 2011, A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION AT L4-5 LEVELS. ON (B)(6) 2013, DURING A 24 MONTH VISIT IT WAS REPORTED "IMPLANT FAILURE, INSTABILITY; PSEUDOARTHROSIS". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 6979704 ↗
• InjuryOct 25, 2017Contamination; Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 A PATIENT UNDERWENT AN INTERLAMINAR LUMBAR INSTRUMENTED FUSION PROCEDURE AT L5-S1 LEVELS WITHOUT ISSUE. DURING FOLLOW UP IT WAS OBSERVED THAT THE INCISION SITE WAS NOT HEALING. ON (B)(6) 2017 A REVISION PROCEDURE TOOK PLACE TO REMOVE THE IMPLANTS WITHOUT REPORTED ISSUE.

  Patient problems: Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 6977868 ↗
• InjuryOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, A PATIENT UNDERWENT INTERLAMINAR LUMBAR INSTRUMENTED FUSION. DURING POST-OP VISIT AN INFECTION AND HEMATOMA WERE NOTED. AN INCISION AND DRAINAGE OF THE WOUND WERE PERFORMED. PATIENT WAS TREATED WITH IV AND ANTIBIOTICS.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 6976038 ↗
• InjuryOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING CLINICAL STUDY IT WAS NOTED THAT PATIENT HAD A NEUROLOGICAL INJURY, INCONTINENCE. IN (B)(6) 2010, THE PATIENT UNDERWENT SURGERY TO REMOVE BOWEL BLOCKAGE AND WAS HOSPITALIZED FOR 1 WEEK. PATIENT WAS TREATED WITH EXERCISE THERAPY.

  Patient problems: Incontinence; Pain

  MAUDE report 6975769 ↗