OBERDORF SYNTHES PRODUKTIONS GMBH

FDA MAUDE device safety record · 2012–2022

What the Data Shows About OBERDORF SYNTHES PRODUKTIONS GMBH

OBERDORF SYNTHES PRODUKTIONS GMBH is associated with 16,864 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2012 through 2022. Of the total, 20 are coded as death reports and 11,455 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 OBERDORF SYNTHES PRODUKTIONS GMBH should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Injury at 11,455 reports (67.9% of total). Patient-outcome categorizations are reported across 7 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 6 years of MAUDE data, with the peak single-year volume reaching 7,269 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.

16,864
Total Reports
20
Death Reports
11,455
Injury Reports
20
Device Types

Event Types

Injury 11,455 (67.9%)
Malfunction 5,389 (32.0%)
Death 20 (0.1%)

Patient Outcomes

Required Intervention 11,336 (67.2%)
5,499 (32.6%)
Death 20 (0.1%)
R 13 (0.1%)
Life Threatening 5 (0.0%)
Hospitalization 3 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

12
2012: 3
17
2017: 155
18
2018: 3,939
19
2019: 7,269
20
2020: 5,497
22
2022: 1

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.