Tritanium PL 48950096Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327117318), received between Mar 18, 2018 and Jun 9, 2023 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING IMPLANTATION OF A TRITANIUM POSTERIOR LUMBAR CAGE, THE SURGEON PENETRATED THE ANTERIOR LONGITUDINAL LIGAMENT. THE CAGE WAS LEFT IN PLACE. THE SURGEON HAS PLANNED ADDITIONAL IMAGING AND ANGIOGRAPHY.

  Patient problems: Peritoneal Laceration(s)

  MAUDE report 17097521 ↗
• InjuryJun 5, 2023Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 6 MONTHS POST-OPERATIVELY TO ADDRESS A MIGRATED TRI PL CAGE AND A 'LOOSENED' XIA POLYAXIAL SCREW. THIS REPORT IS FOR THE TRI PL CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059246 ↗
• MalfunctionMar 4, 2022Fracture; Fracture

  A PHYSICIAN REPORTED THAT A TRITANIUM PL CAGE AT L5 FRACTURED ONE YEAR POSTOPERATIVELY. REVISION SURGERY HAS NOT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667299 ↗
• MalfunctionNov 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY DURING IN SITU CAGE PLACEMENT AT L5-S1. THE REPRESENTATIVE REPORTED THAT THE DISC SPACE WAS NOT DISTRACTED AND TRIALING WAS NOT PERFORMED PRIOR TO IMPLANT PLACEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND ALL THE FRACTURED PIECES WERE REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 25 MINUTE SURGICAL DELAY BY USING AN ALTERNATIVELY AVAILABLE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10819823 ↗
• MalfunctionJun 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT AFTER INTRA-OPERATIVE PLACEMENT OF A TRITANIUM PL CAGE, THE SURGEON DECIDED TO CHANGE THE CAGE SIZE. DURING REMOVAL OF THE CAGE WITH THE INSERTER, THE CAGE FRACTURED AND PART OF IT REMAINED INSIDE THE PATIENT WHILE THE OTHER PART CAME OUT. THE FRACTURED CAGE WAS LEFT IN THE PATIENT AND THE INTERVERTEBRAL SPACE WAS PACKED WITH AUTOLOGOUS BONE TO PREVENT IT FROM MOVING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10155564 ↗
• InjuryNov 12, 2019Migration; Migration

  PHYSICIAN REPORTED THAT A PATIENT EXPERIENCED NUMBNESS AND IT WAS CONFIRMED VIA X-RAY THAT A TRITANIUM PL CAGE PLACED IN L4/5 MIGRATED POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury; Numbness

  MAUDE report 9312058 ↗
• InjuryJun 21, 2019Fracture; Device Dislodged or Dislocated

  PRIMARY SURGERY USING ES2 SYSTEM WAS PERFORMED (B)(6) 2017. IT WAS REPORTED THAT THE SCREW DEVIATED FROM THE VERTEBRAL BODY POSTOPERATIVELY AND THE CAGE FRACTURED AT L3/4. PATIENT WAS REVISED ON (B)(6) 2019. THIS RECORD REPRESENTS THE SCREW.

  Patient problems: Injury

  MAUDE report 8724911 ↗
• MalfunctionJun 8, 2018Device Dislodged or Dislocated; Unintended Movement; Migration; Migration

  IT WAS REPORTED THAT WHEN THE CAGE WAS INSERTED, IT PROTRUDED EXTERIORLY BECAUSE IT WAS INSERTED TOWARDS THE EXTERIOR. THE INSERTER WAS RE-ATTACHED TO THE CAGE AND REPOSITIONED. HOWEVER, THE CAGE WAS DROPPED OUT FROM THE VERTEBRAL BODY POST OPERATIVELY. CURRENTLY THE PATIENT HAS NO SUBJECTIVE SYMPTOMS, SO THE SURGEON DECIDED NOT TO TAKE ADDITIONAL TREATMENT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 7583768 ↗
• InjuryMar 18, 2018Fracture; Fracture; Appropriate Device Problem Term/Code Not Available

  A PATIENT WHO WAS IMPLANTED WITH A CAGE IN (B)(6), REPORTED PAIN AFTER THE OPERATION. IT WAS FURTHER REPORTED THAT THE PATIENT COULD NOT WALK AT ALL, A "BLACK SHADOW LIKE A FOREIGN OBJECT" RESPONSE WAS SEEN ON CT IMAGES, SYMPTOMS IMPROVED AS A RESULT OF BLOCK INJECTIONS ON THE INTERVERTEBRAL DISC AND THAT "THE INTERVERTEBRAL DISCS ARE DOING BAD THINGS". THE CAGE WAS REMOVED ON (B)(6) DURING A REVISION SURGERY. IT WAS OBSERVED THAT THE CASE DID NOT FUSE. AFTER PALPATING THE AFFECTED AREA, AFTER REMOVAL, THERE WAS NO CAVITY AND NORMAL.

  Patient problems: Injury; Pain

  MAUDE report 7347922 ↗