Tritanium PL 48950116Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327117356), received between Aug 28, 2017 and Feb 4, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED TO ADDRESS A TRITANIUM PL CAGE AND AN ES2 SCREW THAT MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT DURING THE REVISION SURGERY, IT WAS OBSERVED THAT TWO ADDITIONAL ES2 SCREWS MIGRATED POST-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS WORKING IN THE FIELDS ONE MONTH POST-OPERATIVELY. THIS REPORT CAPTURES THE CAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306620 ↗
• InjuryNov 21, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WITH NEUROLOGICAL SYMPTOMS WAS REVISED APPROXIMATELY 2.5 YEARS POST-OPERATIVELY TO ADDRESS TWO MIGRATED TRITANIUM POSTERIOR LUMBAR CAGES THAT WERE IN CONTACT WITH A NERVE. UPON CAGE REMOVAL DURING THE REVISION SURGERY, THE CAGES FRACTURED INTRA-OPERATIVELY (ADDRESSED IN PI (B)(4)). THE FRACTURED COMPONENTS OF THE CAGES WERE EXPLANTED, HOWEVER THE REST OF THE CAGES REMAINED IMPLANTED. THE CAGE SURFACES WERE SMOOTHED AND DECOMPRESSION WAS SUCCESSFULLY COMPLETED TO ALLEVIATE THE NEUROLOGICAL SYMPTOMS. THIS REPORT CAPTURES THE SECOND OF THE TWO MIGRATED CAGES.

  Patient problems: Neuropathy

  MAUDE report 20748582 ↗
• InjuryNov 21, 2024Migration; Migration

  IT WAS REPORTED THAT A PATIENT WITH NEUROLOGICAL SYMPTOMS WAS REVISED APPROXIMATELY 2.5 YEARS POST-OPERATIVELY TO ADDRESS TWO MIGRATED TRITANIUM POSTERIOR LUMBAR CAGES THAT WERE IN CONTACT WITH A NERVE. UPON CAGE REMOVAL DURING THE REVISION SURGERY, THE CAGES FRACTURED INTRA-OPERATIVELY (ADDRESSED IN PI (B)(6)). THE FRACTURED COMPONENTS OF THE CAGES WERE EXPLANTED, HOWEVER THE REST OF THE CAGES REMAINED IMPLANTED. THE CAGE SURFACES WERE SMOOTHED AND DECOMPRESSION WAS SUCCESSFULLY COMPLETED TO ALLEVIATE THE NEUROLOGICAL SYMPTOMS. THIS REPORT CAPTURES THE FIRST OF THE TWO MIGRATED CAGES.

  Patient problems: Neuropathy

  MAUDE report 20748443 ↗
• MalfunctionNov 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WITH NEUROLOGICAL SYMPTOMS WAS REVISED APPROXIMATELY 2.5 YEARS POST-OPERATIVELY TO ADDRESS TWO MIGRATED TRITANIUM POSTERIOR LUMBAR CAGES (ADDRESSED IN PI (B)(6)). WHILE ATTEMPTING TO REMOVE THE TWO LUMBAR CAGES WITH AN AVS SPACER INSERTER, BOTH CAGES FRACTURED AND THE INSERTER DEFORMED INTRA-OPERATIVELY. THE FRACTURED COMPONENTS OF THE CAGES WERE EXPLANTED, HOWEVER THE REST OF THE CAGES REMAINED IMPLANTED. THE CAGE SURFACES WERE SMOOTHED AND DECOMPRESSION WAS SUCCESSFULLY COMPLETED TO ALLEVIATE THE NEUROLOGICAL SYMPTOMS. THIS REPORT CAPTURES THE SECOND OF TWO LUMBAR CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747670 ↗
• MalfunctionNov 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WITH NEUROLOGICAL SYMPTOMS WAS REVISED APPROXIMATELY 2.5 YEARS POST-OPERATIVELY TO ADDRESS TWO MIGRATED TRITANIUM POSTERIOR LUMBAR CAGES (ADDRESSED IN (B)(6)). WHILE ATTEMPTING TO REMOVE THE TWO LUMBAR CAGES WITH AN AVS SPACER INSERTER, BOTH CAGES FRACTURED AND THE INSERTER DEFORMED INTRA-OPERATIVELY. THE FRACTURED COMPONENTS OF THE CAGES WERE EXPLANTED, HOWEVER THE REST OF THE CAGES REMAINED IMPLANTED. THE CAGE SURFACES WERE SMOOTHED AND DECOMPRESSION WAS SUCCESSFULLY COMPLETED TO ALLEVIATE THE NEUROLOGICAL SYMPTOMS. THIS REPORT CAPTURES THE FIRST OF TWO LUMBAR CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747618 ↗
• MalfunctionJul 1, 2020Microbial Contamination of Device; Migration; Microbial Contamination of Device; Migration

  IT WAS REPORTED THAT TWO TRITANIUM PL CAGES MIGRATED POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC, THEREFORE NO REVISION SURGERY HAS BEEN SCHEDULED. THIS REPORT REPRESENTS THE FIRST OF THE TWO CAGES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218089 ↗
• MalfunctionJul 1, 2020Migration; Migration

  IT WAS REPORTED THAT TWO TRITANIUM PL CAGES MIGRATED POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC, THEREFORE NO REVISION SURGERY HAS BEEN SCHEDULED. THIS REPORT REPRESENTS THE SECOND OF THE TWO CAGES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217977 ↗
• InjuryJun 6, 2019Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT ONE OF THE TWO CAGES MIGRATED POST-OPERATIVELY. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8674331 ↗
• MalfunctionAug 28, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; UPON ROTATING CAGE THE CAGE BROKE IN HALF ALMOST AT THE MIDLINE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6824483 ↗