SPR Plus 2790Recalls & reported problems
Stryker Corporation · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327175042), received between Mar 23, 2023 and Oct 29, 2024 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Too Soft/Flexible7
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Pressure Sore/Ulcer1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED SAGGING, TOO SOFT, OR NOT FIRM ENOUGH. THERE WERE 2 EVENTS WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20560243 ↗MalfunctionJul 24, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SAGGING, TOO SOFT, OR NOT FIRM ENOUGH. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19819160 ↗MalfunctionJun 18, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE THAT THE SEAM ON THE SPR+ OVERLAY IS COMING APART. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560579 ↗MalfunctionJun 18, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE CUSHION HAD A PINHOLE LEAK CAUSING IT TO DEFLATE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560543 ↗MalfunctionJun 18, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE SPR OVERLAY IS LEAKING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560540 ↗MalfunctionJun 18, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE CUSHION HAD A PINHOLE LEAK CAUSING IT TO DEFLATE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560533 ↗MalfunctionJun 18, 2024Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE OVERLAY KEEPS TEARING AT THE SEAMS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560523 ↗InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PRESSURE INJURY OCCURRED AND IT WAS LATER DISCOVERED THAT THE MATTRESS OVERLAY WAS DEFECTIVE. FURTHER INFORMATION HAS NOT BEEN PROVIDED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16601550 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.