Device brand name · Universal driver
Incompass: medical device reports filed with FDA
170 reports name it, 2005–2008. Manufacturer given most often on reports: Abbott Spine. Product code HXX.
- 170
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 57.1%
- classified as malfunction
- 92.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
170 medical device reports received by FDA name the brand "Incompass" (universal driver); the manufacturer given most often on reports is Abbott Spine; received from January 2005 to July 2008. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (57.1%), injury (40.6%) and other (2.4%); across all screwdriver reports (product code HXX) death is recorded in 0% and malfunction in 92.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are bent (37.6%), replace (28.2%) and explanted (20%). The patient problems coded most often are surgery, prolonged, surgical procedure, repeated and no patient involvement. 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 Incompass was received in the five years to August 2026; the latest was received in July 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 23,401 reports carrying product code HXX. 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 |
|---|---|---|---|
| Bent | 64 | 37.6% | 1.5% |
| Replace | 48 | 28.2% | 0.6% |
| Explanted | 34 | 20% | 0.1% |
| Difficult to removethe device was hard to remove | 26 | 15.3% | 1% |
| Device, removal of (non-implant) | 21 | 12.4% | 0.4% |
| Breakthe device broke | 16 | 9.4% | 46.7% |
| Material separation | 15 | 8.8% | 0.6% |
| Disassembly | 9 | 5.3% | 0.1% |
| Component(s), broken | 7 | 4.1% | 0.2% |
| Disengaged | 7 | 4.1% | 0.1% |
| Component falling | 5 | 2.9% | 0.3% |
| Component(s), worn | 5 | 2.9% | 0.1% |
| Detachment of device component | 5 | 2.9% | 2.1% |
| Sticking | 5 | 2.9% | 0.5% |
| Tip breakage | 5 | 2.9% | 1.9% |
| Device issuea problem with the device | 4 | 2.4% | 0.1% |
| Difficult to insertthe device was hard to insert | 4 | 2.4% | 0.3% |
| Implant, removal of | 4 | 2.4% | 0% |
| Device damaged prior to usethe device was damaged before use | 3 | 1.8% | 0.2% |
| Material fragmentation | 3 | 1.8% | 1.3% |
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 |
|---|---|---|
| Surgery, prolonged | 38 | 22.4% |
| Surgical procedure, repeated | 35 | 20.6% |
| No patient involvement | 22 | 12.9% |
| Foreign body, removal of | 16 | 9.4% |
| Therapy/non-surgical treatment, additional | 6 | 3.5% |
| Painpain, site not specified | 5 | 2.9% |
| Identified diagnosis | 4 | 2.4% |
| Surgical procedure, delayed | 4 | 2.4% |
| Surgical procedure | 3 | 1.8% |
| Cerebrospinal fluid leakage | 1 | 0.6% |
| Dural tear | 1 | 0.6% |
| Falla fall | 1 | 0.6% |
| Hospitalization required | 1 | 0.6% |
| Impaired healingslow healing | 1 | 0.6% |
| Inflammationinflammation | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Incompass | Product code HXX | All MAUDE reports |
|---|---|---|---|
| Reports | 170 | 23,401 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 40.6% | 6.7% | 36.2% |
| Classified as malfunction | 57.1% | 92.7% | 62.3% |
| Filed by the manufacturer | 99.4% | 98.6% | 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 HXX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Locking Screwdriver Body | 967 | 17 | 0% |
| Quickset Taper Hex Scdr Rigid | 642 | 0 | 0% |
| Manual Orthopedic Surgical Instrument | 1,693 | 0 | 0.1% |
| CD HORIZON Spinal System | 9,787 | 634 | 0.3% |
| Quickset Tprd Hex Scdr U-Joint | 556 | 12 | 0% |
| Xpdm Quick-Con Si Poly Scwdrvr | 446 | 13 | 0% |
| Cd Horizon Solera 5 5/6 0 | 478 | 131 | 0% |
| Screwdriver | 396 | 15 | 0% |
| Quickset Ratchet Scdr Hdl | 408 | 29 | 0% |
| Stardrive Scrwdrvr Shft/T4 50mm/Self-Retaining/Hxc | 339 | 16 | 0% |
| Plug Driver | 308 | 38 | 0% |
| Stardrive Screwdriver Shaft T8 105mm | 329 | 43 | 0% |
| Cannulated 4 0mm Hexagonal Screwdriver | 278 | 9 | 0% |
| Hand Piece For Battery Powered Driver | 558 | 66 | 0% |
| Viper Universal Poly Driver | 217 | 3 | 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 Incompass reports
How many FDA reports name Incompass?
170 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 (57.1%), injury (40.6%) and other (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
bent (37.6%), replace (28.2%), explanted (20%), difficult to remove (15.3%) and device, removal of (non-implant) (12.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Incompass 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.