PlainHospital

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Manufacturer adverse-event records for IMPLANT DIRECT SYBRON MANUFACTURING LLC 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 · 2015–2025 · heavy-book · quiet Death-code · injury-heavy

Death-code intensity

IMPLANT DIRECT SYBRON MANUFACTURING LLC is quieter on Death-coded events

Death-coded event_type rows are 0 of 32,190 (0.00% · quiet tercile among 434 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for IMPLANT DIRECT SYBRON MANUFACTURING LLC

The standout signal for IMPLANT DIRECT SYBRON MANUFACTURING LLC is Death-code intensity: 0.00% of 32,190 reports (quiet tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair IMPLANT DIRECT SYBRON MANUFACTURING LLC 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 10 device types, led in this extract by Injury at 31,509 (97.9% of event_type total). Peak single-year volume reaches 7,487 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

32,190
Total Reports
0
Event-type Death
31,509
Injury Reports
10
Device Types

Event Types

Injury 31,509 (97.9%)
Malfunction 680 (2.1%)
1 (0.0%)

Patient Outcomes

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

Required Intervention 31,448 (97.3%)
621 (1.9%)
R 80 (0.2%)
Other 35 (0.1%)
Hospitalization 31 (0.1%)
O 21 (0.1%)
S 21 (0.1%)
Congenital Anomaly 17 (0.1%)
H 16 (0.0%)
L 12 (0.0%)
Death 11 (0.0%)
Life Threatening 7 (0.0%)
Disability 1 (0.0%)

Devices (10)

Device Reports
Implant, Endosseous, Root-Form 31,776
Accessories, Implant, Dental, Endosseous 205
Abutment, Implant, Dental, Endosseous 163
Drill, Bone, Powered 33
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 5
Gauge, Depth, Instrument, Dental 4
Bone Grafting Material, Animal Source 1
Bone Grafting Material, Human Source 1
Guide, Surgical, Instrument 1
Tympanometer 1

Yearly Trend

15
2015: 1
16
2016: 3
17
2017: 7
18
2018: 334
19
2019: 6,147
20
2020: 7,406
21
2021: 7,487
22
2022: 6,317
23
2023: 4,484
24
2024: 3
25
2025: 1

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