Devices › Filler, bone void, calcium compound
Device brand name · Filler bone void calcium compound
Osferion: medical device reports filed with FDA
171 reports name it, 2012–2026. Manufacturer given most often on reports: Olympus Terumo Biomaterials Mishima Factory. Product code MQV.
- 171
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 7
- reports, 12 months to August 2026
- 9 in the 12 months before
- 2.3%
- classified as malfunction
- 22.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
171 medical device reports received by FDA name the brand "Osferion" (filler bone void calcium compound); the manufacturer given most often on reports is Olympus Terumo Biomaterials Mishima Factory; received from October 2012 to April 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
7 reports arrived in the 12 months to August 2026, down 22% from 9 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 injury (91.2%), other (6.4%) and malfunction (2.3%); across all filler, bone void, calcium compound reports (product code MQV) death is recorded in 2.2% and malfunction in 22.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (28.1%), fracture (12.3%) and insufficient device problem information (2.9%). The patient problems coded most often are pain, bone fracture(s) and skin discoloration. 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 2,073 reports carrying product code MQV. 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 |
|---|---|---|---|
| Breakthe device broke | 48 | 28.1% | 5.2% |
| Fracturea broken bone | 21 | 12.3% | 2.3% |
| Insufficient device problem information | 5 | 2.9% | 18.5% |
| Collapse | 3 | 1.8% | 0.4% |
| Malposition of device | 3 | 1.8% | 0.3% |
| Material protrusion/extrusion | 3 | 1.8% | 0.1% |
| Crackthe device cracked | 2 | 1.2% | 0.8% |
| Failure to advance | 2 | 1.2% | 0.1% |
| Migration or expulsion of device | 2 | 1.2% | 3.5% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 1.2% | 1.9% |
| Positioning problem | 2 | 1.2% | 0.2% |
| Computer operating system problem | 1 | 0.6% | 0% |
| Device dislodged or dislocated | 1 | 0.6% | 0.7% |
| Device or device fragments location unknown | 1 | 0.6% | 0% |
| Device slipped | 1 | 0.6% | 0.4% |
| Expiration date error | 1 | 0.6% | 0.2% |
| Failure to align | 1 | 0.6% | 0% |
| Improper or incorrect procedure or method | 1 | 0.6% | 1.4% |
| Inadequacy of device shape and/or size | 1 | 0.6% | 0% |
| Loose or intermittent connection | 1 | 0.6% | 0.2% |
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 |
|---|---|---|
| Painpain, site not specified | 30 | 17.5% |
| Bone fracture(s) | 16 | 9.4% |
| Skin discoloration | 15 | 8.8% |
| Post operative wound infection | 10 | 5.8% |
| Swellingswelling | 8 | 4.7% |
| Failure of implant | 7 | 4.1% |
| Fluid discharge | 5 | 2.9% |
| Skin infection | 5 | 2.9% |
| Discomfortdiscomfort | 4 | 2.3% |
| Implant pain | 4 | 2.3% |
| Erythemaskin redness | 3 | 1.8% |
| Inflammationinflammation | 3 | 1.8% |
| Paralysis | 3 | 1.8% |
| Eczemaeczema | 2 | 1.2% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Osferion | Product code MQV | All MAUDE reports |
|---|---|---|---|
| Reports | 171 | 2,073 | 26,136,888 |
| Share of that pool | — | 8.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 22 | 9 |
| Classified as injury | 91.2% | 64.4% | 36.2% |
| Classified as malfunction | 2.3% | 22.7% | 62.3% |
| Filed by the manufacturer | 100% | 93.3% | 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 MQV
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Infuse Bone Graft | 12,081 | 36 | 0.3% |
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 Osferion reports
How many FDA reports name Osferion?
171 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.
What kinds of events are reported?
injury (91.2%), other (6.4%) and malfunction (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (28.1%), fracture (12.3%), insufficient device problem information (2.9%), collapse (1.8%) and malposition of device (1.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Osferion 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.