INTEGRA LIFESCIENCES CORPORATION OH/USA

FDA MAUDE device safety record · 2011–2026

What the Data Shows About INTEGRA LIFESCIENCES CORPORATION OH/USA

INTEGRA LIFESCIENCES CORPORATION OH/USA is associated with 5,611 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2011 through 2026. Of the total, 6 are coded as death reports and 1,260 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 INTEGRA LIFESCIENCES CORPORATION OH/USA should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 4,344 reports (77.4% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 16 years of MAUDE data, with the peak single-year volume reaching 1,090 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.

5,611
Total Reports
6
Death Reports
1,260
Injury Reports
20
Device Types

Event Types

Malfunction 4,344 (77.4%)
Injury 1,260 (22.5%)
Death 6 (0.1%)
Other 1 (0.0%)

Patient Outcomes

4,924 (86.8%)
Other 403 (7.1%)
Required Intervention 241 (4.2%)
R 83 (1.5%)
Death 8 (0.1%)
Disability 5 (0.1%)
Hospitalization 5 (0.1%)
O 1 (0.0%)
S 1 (0.0%)

Yearly Trend

11
2011: 26
12
2012: 193
13
2013: 205
14
2014: 186
15
2015: 267
16
2016: 393
17
2017: 331
18
2018: 296
19
2019: 1,090
20
2020: 915
21
2021: 727
22
2022: 290
23
2023: 240
24
2024: 179
25
2025: 245
26
2026: 28

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.