EXACTECH, INC.

FDA MAUDE device safety record · 1994–2026

What the Data Shows About EXACTECH, INC.

EXACTECH, INC. is associated with 19,835 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1994 through 2026. Of the total, 14 are coded as death reports and 17,808 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for EXACTECH, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Injury at 17,808 reports (89.8% of total). Patient-outcome categorizations are reported across 15 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 31 years of MAUDE data, with the peak single-year volume reaching 5,088 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

19,835
Total Reports
14
Death Reports
17,808
Injury Reports
20
Device Types

Event Types

Injury 17,808 (89.8%)
Malfunction 1,292 (6.5%)
Other 697 (3.5%)
24 (0.1%)
Death 14 (0.1%)

Patient Outcomes

Required Intervention 12,427 (46.3%)
Hospitalization 4,711 (17.6%)
R 3,770 (14.1%)
H 2,472 (9.2%)
1,531 (5.7%)
Other 932 (3.5%)
S 576 (2.1%)
O 201 (0.7%)
Disability 146 (0.5%)
Life Threatening 27 (0.1%)
Death 14 (0.1%)
D 6 (0.0%)
L 5 (0.0%)
Congenital Anomaly 3 (0.0%)
C 1 (0.0%)

Yearly Trend

94
1994: 1
96
1996: 3
97
1997: 11
98
1998: 9
99
1999: 2
00
2000: 17
01
2001: 13
02
2002: 25
03
2003: 26
04
2004: 21
05
2005: 19
06
2006: 20
07
2007: 42
08
2008: 47
09
2009: 71
10
2010: 159
11
2011: 77
12
2012: 87
13
2013: 169
14
2014: 578
15
2015: 331
17
2017: 712
18
2018: 986
19
2019: 705
20
2020: 1,058
21
2021: 804
22
2022: 1,807
23
2023: 3,081
24
2024: 5,088
25
2025: 3,659
26
2026: 207

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.