Symphysis Plate 21161-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120034302961), received between Dec 6, 2021 and Dec 6, 2021 — classified as 1 malfunction.

2 other recalls cover devices cleared under the same FDA submission (K063166); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A SYMPHYSIS PLATE 6-HOLE BROKE 2 MONTHS POST-OP TWO TIMES AFTER FIXATION OF A SYMPHYSIS DISRUPTION. PLATE BREAKAGE WAS NOTICED DURING ROUTINE X-RAY.

  Patient problems: Insufficient Information

  MAUDE report 12932327 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063166. One submission often covers many models, so check the product and lot details in each record.

• Z-1600-2026 · Jan 23, 2026 · Open, Classified
  Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 7031
• Z-1718-2019 · May 9, 2019 · Open, Classified
  Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After th