VertePortRecalls & reported problems across all models

We found 2 models of VertePort by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2018 and May 8, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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

VertePort 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-1247-2018 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported VertePort problems

VertePort models

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

• VertePort 0306511000

  Injector, vertebroplasty (does not contain cement)
  1 recall0 reports
• VertePort 0306410000

  Injector, vertebroplasty (does not contain cement)
  2 reports

Recent VertePort adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS A HAIR IN THE STERILE PACKAGING. THERE WAS NO ASSOCIATED PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8591244 ↗
• MalfunctionNov 21, 2018Unsealed Device Packaging; Contamination /Decontamination Problem; Unsealed Device Packaging; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE STERILE PACKAGING TORE DOWN SIDEWAYS UPON OPENING THE DEVICE AND CONTAMINATED THE PRODUCT. THERE WAS NO ASSOCIATED PROCEDURE AND THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8096209 ↗

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