PCDRecalls & reported problems across all models

We found 3 models of PCD by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2018 and Jul 23, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PCD recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 9, 2017Terminated

   Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

   Z-1249-2018 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported PCD problems

PCD models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PCD 0506485000

  Injector, vertebroplasty (does not contain cement)
  1 recall0 reports
• PCD 0506486000

  MIXER, CEMENT, FOR CLINICAL USE
  2 reports
• PCD 0506483000

  MIXER, CEMENT, FOR CLINICAL USE
  1 report

Recent PCD adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTED FOUND TO HAVE A TEAR, RIP, OR HOLE IN THE DEVICE PACKAGING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8816613 ↗
• MalfunctionDec 19, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT THE STERILITY OF THE DEVICE PACKAGING IS BEING COMPROMISED BY A LOOSE ITEM INSIDE OF THE BOX. THERE WAS NO ASSOCIATED PROCEDURE AND THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8178693 ↗
• MalfunctionDec 19, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT THE STERILITY OF THE DEVICE PACKAGING IS BEING COMPROMISED BY A LOOSE ITEM INSIDE OF THE BOX. THERE WAS NO ASSOCIATED PROCEDURE AND THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8178692 ↗

Other Stryker Corporation products

• RemB7 models · 3,073 reports
• Prime Series21 models · 1,548 reports · 2 recalls
• TARGET114 models · 1,077 reports
• ProCuity17 models · 368 reports · 13 recalls
• Spetzler-Malis20 models · 7 reports · 19 recalls
• SYNCHRO 28 models · 313 reports · 9 recalls
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls