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2026 data FDA MAUDE openFDA FDA Class II

Sacroiliac Joint Fixation

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 §888.3040 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Sacroiliac Joint Fixation LIGHT-BOOK · MAUDE

#587 of 1000 · 1,406 reports · 2011–2026

  • BOOK 1,406 reports
  • RANK #587 of 1000
  • DEATH 5 death-typed
  • INJ 1,352 injury-typed
  • MALF 15 malfunction
  • SPAN 2011–2026
  • PEAK 2019: 175
  • PHOTO Unit, Operative Dental

Nearest event-volume peer: Unit, Operative Dental (1 report gap)

Sacroiliac Joint Fixation sits #587 of 1000 among tracked device types with 1,406 MAUDE reports spanning 2011–2026. 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

Sacroiliac Joint Fixation carries 96.2% INJURY-coded reports, 65.9pp 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 (-1.2 pp)
  • INJ 96.2% corpus 30.3% · above corpus mean (+65.9 pp)
  • MALF 1.1% corpus 64.8% · below corpus mean (-63.8 pp)

Lead product-problem code Malposition of Device is 44% of coded problems · Lead manufacturer MEDACTA INTERNATIONAL SA accounts for 62% of manufacturer-tagged reports · Top event location I is 65% of location-tagged rows .

Sacroiliac Joint Fixation in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Sacroiliac Joint Fixation carries 1,406 MAUDE reports, ranked #587 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 1,352 (96.2%)
Other 27 (1.9%)
Malfunction 15 (1.1%)
7 (0.5%)
Death 5 (0.4%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 1,038 (69.2%)
Other 281 (18.7%)
Hospitalization 53 (3.5%)
R 52 (3.5%)
O 27 (1.8%)
21 (1.4%)
H 6 (0.4%)
L 6 (0.4%)
Death 5 (0.3%)
S 4 (0.3%)
Disability 4 (0.3%)
Congenital Anomaly 2 (0.1%)
Life Threatening 2 (0.1%)

Top Product Problems

Malposition of Device 675
Adverse Event Without Identified Device or Use Problem 319
Loss of Osseointegration 100
Inadequacy of Device Shape and/or Size 81
Insufficient Device Problem Information 79
Positioning Problem 37
Device Operates Differently Than Expected 29
Device Slipped 28
Failure to Osseointegrate 27
Appropriate Device Problem Term/Code Not Available 26
Difficult to Remove 22
Improper or Incorrect Procedure or Method 22
Break 16
Migration or Expulsion of Device 16
Device Dislodged or Dislocated 9
Device Handling Problem 7
Fitting Problem 7
Fracture 7
Entrapment of Device 5
Loose or Intermittent Connection 5

Yearly Trend

11
2011: 6
12
2012: 81
13
2013: 96
14
2014: 146
15
2015: 119
16
2016: 122
17
2017: 157
18
2018: 137
19
2019: 175
20
2020: 148
21
2021: 154
22
2022: 23
23
2023: 7
24
2024: 15
25
2025: 10
26
2026: 10

Reports in 2025 (10) held close to the prior two-year average of 11.

Related Entities for Sacroiliac Joint Fixation

Top Manufacturers

MEDACTA INTERNATIONAL SA 8
MEDTRONIC SOFAMOR DANEK USA, INC 5

Event Locations

I 916 (65.1%)
484 (34.4%)
NO INFORMATION 5 (0.4%)
HOSPITAL 1 (0.1%)

Compare MEDACTA INTERNATIONAL SA vs MEDTRONIC SOFAMOR DANEK USA, INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Sacroiliac Joint Fixation: 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 (1,406 here).

Unit, Operative Dental 1,407 Lens, Intraocular, Accommodative 1,402 Locator, Root Apex 1,412 Dressing, Wound, Hydrophilic 1,397

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Sacroiliac Joint Fixation 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 Sacroiliac Joint Fixation; 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.