PlainHospital

SYNTHES GMBH

Manufacturer adverse-event records for SYNTHES GMBH come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2008–2026 · heavy-book · quiet Death-code · balanced

Volume signature

SYNTHES GMBH sits in the heavy MAUDE book

SYNTHES GMBH accounts for 74,348 FDA MAUDE reports (#43 of 443, heavy-book tercile). Death-coded event_type share is 0.06% (quiet); Injury share 26.9% (balanced).

What the volume reading shows for SYNTHES GMBH

The standout signal for SYNTHES GMBH is filing volume: 74,348 adverse-event reports in FDA MAUDE (#43 of 443, heavy-book). Death-coded event_type share sits at 0.06% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair SYNTHES GMBH with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Malfunction at 54,291 (73.0% of event_type total). Peak single-year volume reaches 14,070 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

74,348
Total Reports
43
Event-type Death
20,006
Injury Reports
20
Device Types

Event Types

Malfunction 54,291 (73.0%)
Injury 20,006 (26.9%)
Death 43 (0.1%)
8 (0.0%)

Patient Outcomes

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

54,229 (73.2%)
Required Intervention 19,338 (26.1%)
Other 344 (0.5%)
R 56 (0.1%)
Death 38 (0.1%)
O 18 (0.0%)
Hospitalization 16 (0.0%)
S 14 (0.0%)
D 6 (0.0%)
Congenital Anomaly 5 (0.0%)
Life Threatening 4 (0.0%)
H 3 (0.0%)
L 3 (0.0%)
Disability 2 (0.0%)

Devices (20)

Device Reports
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 12,748
Screw, Fixation, Bone 9,572
Rod, Fixation, Intramedullary And Accessories 5,814
Motor, Surgical Instrument, Ac-Powered 4,728
Plate, Fixation, Bone 4,419
Screwdriver 4,066
Orthopedic Manual Surgical Instrument 4,035
Bit, Drill 2,882
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 2,543
Guide, Surgical, Instrument 2,507
Plate, Bone 2,286
Reamer 1,734
Nail, Fixation, Bone 1,703
Gauge, Depth 1,274
Cement, Bone, Vertebroplasty 1,191
Forceps 783
Thoracolumbosacral Pedicle Screw System 693
Battery, Replacement, Rechargeable 587
Cerclage, Fixation 546
Wire, Surgical 506

Yearly Trend

08
2008: 1
11
2011: 356
12
2012: 1,718
13
2013: 6,105
14
2014: 1,749
15
2015: 1
16
2016: 1
18
2018: 8
19
2019: 9
20
2020: 1,362
21
2021: 9,907
22
2022: 10,971
23
2023: 14,070
24
2024: 13,546
25
2025: 12,569
26
2026: 1,975

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