Devices › Pin, fixation, smooth
Device brand name · External fixation
Ebi Xfix Dynafix: medical device reports filed with FDA
164 reports name it, 1996–2003. Manufacturer given most often on reports: Electro-Biology. Product code HTY.
- 164
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 73.8%
- classified as malfunction
- 45.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 164 reports that name the brand "Ebi Xfix Dynafix" (external fixation), received between November 1996 and November 2003; the manufacturer given most often on reports is Electro-Biology. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (73.8%), injury (21.3%) and other (1.2%); across all pin, fixation, smooth reports (product code HTY) death is recorded in 0% and malfunction in 45.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (43.9%), loose (28%) and component(s), broken (20.1%). The patient problems coded most often are therapy/non-surgical treatment, additional, surgical procedure, repeated and other (for use when an appropriate patient code cannot be identified). 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
No report naming Ebi Xfix Dynafix was received in the five years to August 2026; the latest was received in November 2003.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,889 reports carrying product code HTY. 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 |
|---|---|---|---|
| Replace | 72 | 43.9% | 3.4% |
| Loose | 46 | 28% | 2.5% |
| Component(s), broken | 33 | 20.1% | 2% |
| Breakthe device broke | 10 | 6.1% | 26.1% |
| Explanted | 7 | 4.3% | 3.3% |
| Device, removal of (non-implant) | 6 | 3.7% | 0.6% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 3.7% | 0.4% |
| Repair | 6 | 3.7% | 0.2% |
| Device issuea problem with the device | 5 | 3% | 0.4% |
| Difficult to insertthe device was hard to insert | 5 | 3% | 1% |
| Migration or expulsion of device | 5 | 3% | 1.5% |
| Detachment of device component | 4 | 2.4% | 1.5% |
| Material separation | 4 | 2.4% | 0.4% |
| Loose or intermittent connection | 3 | 1.8% | 0.4% |
| Wire(s), breakage of | 3 | 1.8% | 0.4% |
| Defective component | 2 | 1.2% | 0.1% |
| Device slipped | 2 | 1.2% | 1.2% |
| Device, or device fragments remain in patient | 2 | 1.2% | 2.1% |
| Difficult to position | 2 | 1.2% | 0.1% |
| Failure to align | 2 | 1.2% | 0.1% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 30 | 18.3% |
| Surgical procedure, repeated | 16 | 9.8% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 3% |
| Surgical procedure | 5 | 3% |
| Surgical procedure, additional | 5 | 3% |
| Failure of implant | 2 | 1.2% |
| Nonresorbable materials, unretrieved in body | 2 | 1.2% |
| Post operative wound infection | 2 | 1.2% |
| Foreign body, removal of | 1 | 0.6% |
| Joint disorder | 1 | 0.6% |
| Migrationthe device moved from where it was placed | 1 | 0.6% |
| Nonunion/delayed-union bone fracture | 1 | 0.6% |
| Surgery, prolonged | 1 | 0.6% |
| Therapeutic response, decreased | 1 | 0.6% |
| Therapy/non-surgical treatment, aborted/stopped | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ebi Xfix Dynafix | Product code HTY | All MAUDE reports |
|---|---|---|---|
| Reports | 164 | 2,889 | 26,136,888 |
| Share of that pool | — | 5.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 21.3% | 51.1% | 36.2% |
| Classified as malfunction | 73.8% | 45.2% | 62.3% |
| Filed by the manufacturer | 100% | 92.9% | 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 HTY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Acl Tightrope With Fibertag | 162 | 20 | 0% |
| Acl Tightrope Rt | 176 | 38 | 0% |
| Unknown_InstrumentstIre_Product | 1,475 | 123 | 0% |
| Unknown Apex Pin | 381 | 0 | 0.5% |
| UNK Fixation Pin | 189 | 45 | 0% |
| UNK - Implant | 771 | 80 | 0% |
| Microaire | 176 | 0 | 0.6% |
| Gryphon P Br Ds Anchor W/Oc | 554 | 111 | 0% |
| Synthes | 470 | 0 | 0.6% |
| Truespan 12 Degree Peek | 1,400 | 127 | 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 Ebi Xfix Dynafix reports
How many FDA reports name Ebi Xfix Dynafix?
164 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (73.8%), injury (21.3%) and other (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (43.9%), loose (28%), component(s), broken (20.1%), break (6.1%) and explanted (4.3%). 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 Ebi Xfix Dynafix 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.