PINNACLE 2218-82-750Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295101888), received between Dec 22, 2017 and Oct 12, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  ROUTINE INSPECTION OF INSTRUMENTS. OPENED 4 DIFFERENT SETS OF TRAYS TO INSPECT ITEMS. MULTIPLE ITEMS WITH SCRATCHES AND WEAR AND TEAR REQUIRING REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920210 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021374 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021360 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021328 ↗
• MalfunctionOct 30, 2018Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  COMPLAINT NOT SPECIFIC TO ONE CASE. SURGEONS COMPLAIN THAT PINNACLE POLY TRIALS ARE WORN AND USED, SCRATCHES ON THEM AND SCREWS WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021286 ↗
• MalfunctionDec 22, 2017Break; Break

  BROKEN CERAMIC INSERT TRIAL LINER REPORTED BY NURSE. PLEASE SHIP DIRECTLY TO (B)(6). PATIENT CONSEQUENCE? : NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141651 ↗