Hydrogel Spacer
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §892.5725 (Radiology panel).
FDA MAUDE casebook
openFDA event book Hydrogel Spacer LIGHT-BOOK · MAUDE
#489 of 1000 · 2,087 reports · 2016–2026
- BOOK 2,087 reports
- RANK #489 of 1000
- DEATH 9 death-typed
- INJ 757 injury-typed
- MALF 1,321 malfunction
- SPAN 2016–2026
- PEAK 2022: 387
- PHOTO Catheter
Nearest event-volume peer: Catheter, Percutaneous, Cutting/Scoring (4 report gap)
Hydrogel Spacer sits #489 of 1000 among tracked device types with 2,087 MAUDE reports spanning 2016–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Injury-coded reports run above the device-type norm
Hydrogel Spacer carries 36.3% INJURY-coded reports, 6.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
- INJ 36.3% corpus 30.3% · above corpus mean (+6.0 pp)
- MALF 63.3% corpus 64.8% · below corpus mean (-1.5 pp)
Lead product-problem code Positioning Problem is 57% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 100% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .
Hydrogel Spacer in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Bur
Bur, Surgical, General & Plastic Surgery
2,110 reports
- Agent
Agent, Absorbable Hemostatic, Collagen Based
2,108 reports
- Hydrogel Spac… (this)
Hydrogel Spacer
2,087 reports
- Catheter
Catheter, Percutaneous, Cutting/Scoring
2,083 reports
- Handpiece
Handpiece, Air-Powered, Dental
2,071 reports
- Prosthesis
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
2,066 reports
What this shows Hydrogel Spacer carries 2,087 MAUDE reports, ranked #489 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (340) held close to the prior two-year average of 328.
Related Entities for Hydrogel Spacer
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Hydrogel Spacer: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,087 here).
Similar death-typed counts
Nearest other device types by death-typed report count (9 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Hydrogel Spacer are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Hydrogel Spacer; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.