2.7MM SYSTEM 99-9948Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036058555), received between Oct 10, 2019 and Aug 4, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K854886); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN OPERATION TO CLEAN OUT HER JOINT APPROXIMATELY NINE (9) YEARS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 10364418 ↗
• InjuryMar 10, 2020Migration or Expulsion of Device; Material Integrity Problem; Migration or Expulsion of Device; Material Integrity Problem

  IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES WITH HER BILATERAL TEMPOROMANDIBULAR JOINT PROSTHESES SINCE IMPLANTATION THIRTEEN YEARS AGO. THE PATIENT REPORTED SYMPTOMS AND PROCEDURES INCLUDING NERVE DAMAGE, NEUROMA REMOVAL, X-RAYS, BOTOX INJECTIONS, CT SCAN, PAIN, DIFFICULTY CHEWING, DIFFICULTY EATING AND A PLANNED REVISION. THE PATIENT REPORTED THE NERVE DAMAGE OCCURRED IMMEDIATELY AFTER IMPLANTATION WHICH RESULTED IN HER BEING UNABLE TO BLINK HER RIGHT EYE OR MOVE HER RIGHT EYEBROW. THE PATIENT REPORTED A NEUROMA WAS REMOVED FROM THE RIGHT SIDE OF HER JAW SEVEN YEARS AGO. THE PATIENT REPORTED SHE HAD X-RAYS TAKEN BY A DENTIST AND WAS INFORMED THAT A SCREW ON THE RIGHT SIDE IS NOT INTACT. THE PATIENT REPORTED RECEIVING BOTOX TO HER FACE APPROXIMATELY ONE YEAR AGO TO TREAT PAIN, BUT STATED THAT IT DID NOT PROVIDE RELIEF AND AGGRAVATED THE PAIN FURTHER. THE PATIENT REPORTED A CT SCAN WAS TAKEN FOUR MONTHS AGO AND REVEALED THAT TWO SCREWS ON THE RIGHT SIDE WERE NOT INTACT AND WERE NOT STABLE. THE PATIENT REPORTED SHE HAS EXCRUCIATING PAIN, DIFFICULTY CHEWING, AND DIFFICULTY EATING. SHE STATED DUE TO THE DIFFICULTY EATING, SHE CHOKES ON HER FOOD. ADDITIONALLY, SHE REPOR

  Patient problems: Difficulty Chewing; Facial Nerve Paralysis; Feeding Problem; Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 9811103 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 9520316 ↗
• InjuryOct 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Difficulty Chewing; Pain; Sleep Dysfunction

  MAUDE report 9177343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K854886. One submission often covers many models, so check the product and lot details in each record.

• Z-0108-2011 · Aug 31, 2010 · Terminated
  2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY