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2026 data FDA MAUDE openFDA FDA Class II

External Mandibular Fixator And/Or Distractor

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 §872.4760 (Dental panel).

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FDA MAUDE casebook

openFDA event book External Mandibular Fixator And/Or Distract… LIGHT-BOOK · MAUDE

#584 of 1000 · 1,416 reports · 1997–2026

  • BOOK 1,416 reports
  • RANK #584 of 1000
  • DEATH 3 death-typed
  • INJ 1,065 injury-typed
  • MALF 324 malfunction
  • SPAN 1997–2026
  • PEAK 2013: 179
  • PHOTO Locator, Root Apex

Nearest event-volume peer: Locator, Root Apex (4 report gap)

External Mandibular Fixator And/Or Distractor sits #584 of 1000 among tracked device types with 1,416 MAUDE reports spanning 1997–2026. 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

External Mandibular Fixator And/Or Distract… carries 75.2% INJURY-coded reports, 44.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 75.2% corpus 30.3% · above corpus mean (+44.9 pp)
  • MALF 22.9% corpus 64.8% · below corpus mean (-41.9 pp)

Lead product-problem code Break is 36% of coded problems · Lead manufacturer SYNTHES USA accounts for 24% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

External Mandibular Fixator And/Or Distract… in the event-volume neighbourhood

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

reports

What this shows External Mandibular Fixator And/Or Distractor carries 1,416 MAUDE reports, ranked #584 of 1000.

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

Event Types

Injury 1,065 (75.2%)
Malfunction 324 (22.9%)
Other 21 (1.5%)
3 (0.2%)
Death 3 (0.2%)

Patient Outcomes

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

Other 554 (38.6%)
Required Intervention 520 (36.2%)
313 (21.8%)
Hospitalization 22 (1.5%)
R 14 (1.0%)
O 3 (0.2%)
S 3 (0.2%)
Death 3 (0.2%)
Disability 2 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Break 536
Adverse Event Without Identified Device or Use Problem 263
Device Operates Differently Than Expected 98
Explanted 84
Fracture 69
Detachment Of Device Component 63
Replace 50
Osseointegration Problem 45
Mechanical Jam 39
Insufficient Device Problem Information 35
Material Separation 34
Device Slipped 30
Migration or Expulsion of Device 29
Detachment of Device or Device Component 27
Difficult to Remove 19
Failure to Advance 19
Loose or Intermittent Connection 18
Device Dislodged or Dislocated 15
Improper or Incorrect Procedure or Method 15
Bent 14

Yearly Trend

97
1997: 3
98
1998: 4
99
1999: 8
00
2000: 7
01
2001: 4
02
2002: 13
03
2003: 12
04
2004: 19
05
2005: 24
06
2006: 19
07
2007: 5
08
2008: 8
09
2009: 11
10
2010: 20
11
2011: 26
12
2012: 107
13
2013: 179
14
2014: 57
15
2015: 93
16
2016: 87
17
2017: 75
18
2018: 108
19
2019: 122
20
2020: 86
21
2021: 101
22
2022: 61
23
2023: 39
24
2024: 60
25
2025: 35
26
2026: 23

Reports in 2025 (35) held close to the prior two-year average of 50.

Related Entities for External Mandibular Fixator And/Or Distractor

Top Manufacturers

SYNTHES USA 154
SYNTHES GMBH 143
SYNTHES MONUMENT 119
SYNTHES (USA) 76
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 68
OBERDORF SYNTHES PRODUKTIONS GMBH 45
SYNTHES BRANDYWINE 41

Event Locations

784 (55.4%)
I 393 (27.8%)
HOSPITAL 222 (15.7%)
NO INFORMATION 6 (0.4%)
HOME 4 (0.3%)
NOT APPLICABLE 4 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare SYNTHES USA vs SYNTHES GMBH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for External Mandibular Fixator And/Or Distract…: 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 (1,416 here).

Locator, Root Apex 1,412 Prosthesis 1,423 Unit, Operative Dental 1,407 Sacroiliac Joint Fixation 1,406

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for External Mandibular Fixator And/Or Distract… 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 External Mandibular Fixator And/Or Distract…; 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.