Devices › Active implantable bone conduction hearing system
Device brand name · Bci bone conduction implant
Bonebridge: medical device reports filed with FDA
485 reports name it, 2018–2026. Manufacturer given most often on reports: Med-El Elektromedizinische Geraete. Product code PFO.
- 485
- device reports naming the brand
- 0% of all MAUDE reports · about 62 a year
- 99
- reports, 12 months to August 2026
- 89 in the 12 months before
- 64.9%
- classified as malfunction
- 10.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
485 medical device reports received by FDA name the brand "Bonebridge" (bci bone conduction implant); the manufacturer given most often on reports is Med-El Elektromedizinische Geraete; received from September 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
99 reports arrived in the 12 months to August 2026, up 11% from 89 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (64.9%) and injury (35.1%); across all active implantable bone conduction hearing system reports (product code PFO) death is recorded in 0% and malfunction in 10.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no device output (43.5%), output problem (24.5%) and device appears to trigger rejection (15.3%). The patient problems coded most often are failure of implant, skin tears and tissue breakdown. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,471 reports carrying product code PFO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| No device output | 211 | 43.5% | 6.1% |
| Output problem | 119 | 24.5% | 2.4% |
| Device appears to trigger rejection | 74 | 15.3% | 2.3% |
| Insufficient device problem information | 37 | 7.6% | 4.9% |
| Improper or incorrect procedure or method | 17 | 3.5% | 0.5% |
| Noise, audible | 17 | 3.5% | 0.5% |
| Lack of effect | 10 | 2.1% | 0.2% |
| Loose or intermittent connection | 10 | 2.1% | 0.6% |
| Malposition of device | 10 | 2.1% | 0.4% |
| Migrationthe device moved from where it was placed | 10 | 2.1% | 0.5% |
| Device dislodged or dislocated | 4 | 0.8% | 2.7% |
| Osseointegration problem | 4 | 0.8% | 0.1% |
| Microbial contamination of device | 3 | 0.6% | 0.1% |
| Circuit failure | 2 | 0.4% | 0% |
| Device handling problem | 2 | 0.4% | 0.4% |
| Loosening of implant not related to bone-ingrowth | 1 | 0.2% | 0% |
| Unexpected therapeutic results | 1 | 0.2% | 1.9% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Failure of implant | 251 | 51.8% |
| Skin tears | 44 | 9.1% |
| Tissue breakdown | 23 | 4.7% |
| Head injurya head injury | 17 | 3.5% |
| Implant pain | 13 | 2.7% |
| Post operative wound infection | 11 | 2.3% |
| Painpain, site not specified | 9 | 1.9% |
| Wound dehiscencea wound reopened | 9 | 1.9% |
| Bacterial infectiona bacterial infection | 8 | 1.6% |
| Necrosisdeath of tissue | 7 | 1.4% |
| Headachehead pain | 4 | 0.8% |
| Medical device site infectioninfection at the device site | 3 | 0.6% |
| Pressure sore/ulcer | 3 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.4% |
| Cerebrospinal fluid leakage | 2 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bonebridge | Product code PFO | All MAUDE reports |
|---|---|---|---|
| Reports | 485 | 3,471 | 26,136,888 |
| Share of that pool | — | 14% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 35.1% | 89.3% | 36.2% |
| Classified as malfunction | 64.9% | 10.7% | 62.3% |
| Filed by the manufacturer | 96.1% | 62.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code PFO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cochlear Osia OSI200 Implant | 1,824 | 247 | 0.1% |
| Cochlear Osia OSI300 Implant | 1,110 | 540 | 0% |
| Asku | 4,752 | 210 | 1.1% |
| Nucleus CI522 Cochlear Implant with Slim Straight Electrode | 1,584 | 179 | 0% |
| Nucleus CI422 Cochlear Implant with Slim Straight Electrode | 694 | 52 | 0% |
| Nucleus CI512 Cochlear Implant with Contour Advance Electrode | 2,605 | 232 | 0% |
| Nucleus CI532 Cochlear Implant with Slim Modiolar Electrode | 872 | 82 | 0% |
| Nucleus CI622 Cochlear Implant with Slim Straight Electrode | 2,398 | 510 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Bonebridge reports
How many FDA reports name Bonebridge?
485 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 99 in the latest 12 months.
What kinds of events are reported?
malfunction (64.9%) and injury (35.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no device output (43.5%), output problem (24.5%), device appears to trigger rejection (15.3%), insufficient device problem information (7.6%) and improper or incorrect procedure or method (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.1%), distributor reports (3.7%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bonebridge was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.