Devices › Intervertebral fusion device with bone graft, lumbar
Device brand name · Intervertebal fusion device w/bone graft lumbar
T-Pal Spacer Applicator Handle: medical device reports filed with FDA
157 reports name it, 2013–2023. Manufacturer given most often on reports: Synthes Hagendorf. Product code MAX.
- 157
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 86%
- classified as malfunction
- 63.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 157 reports that name the brand "T-Pal Spacer Applicator Handle" (intervertebal fusion device w/bone graft lumbar), received between February 2013 and December 2023; the manufacturer given most often on reports is Synthes Hagendorf. 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 (86%) and injury (14%); across all intervertebral fusion device with bone graft, lumbar reports (product code MAX) death is recorded in 0.3% and malfunction in 63.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical jam (26.1%), fitting problem (18.5%) and device operates differently than expected (15.9%). The patient problems coded most often are no patient involvement, sedation and tissue damage. 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 9,238 reports carrying product code MAX. 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 |
|---|---|---|---|
| Mechanical jam | 41 | 26.1% | 1.8% |
| Fitting problem | 29 | 18.5% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 25 | 15.9% | 1.9% |
| Device-device incompatibility | 17 | 10.8% | 4.8% |
| Breakthe device broke | 12 | 7.6% | 28.7% |
| Sticking | 9 | 5.7% | 0.2% |
| Separation failure | 6 | 3.8% | 0.2% |
| Compatibility problem | 3 | 1.9% | 1.5% |
| Material integrity problema problem with the device material | 2 | 1.3% | 1.9% |
| Material twisted/bent | 2 | 1.3% | 0.7% |
| Unintended movement | 2 | 1.3% | 0.8% |
| Difficult to position | 1 | 0.6% | 0.3% |
| Difficult to removethe device was hard to remove | 1 | 0.6% | 0.7% |
| Disassembly | 1 | 0.6% | 0.1% |
| Failure to adhere or bond | 1 | 0.6% | 0.2% |
| Loose or intermittent connection | 1 | 0.6% | 0.8% |
| Material fragmentation | 1 | 0.6% | 1.1% |
| Mechanical problema mechanical problem | 1 | 0.6% | 5.7% |
| Positioning problem | 1 | 0.6% | 0.6% |
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 |
|---|---|---|
| No patient involvement | 24 | 15.3% |
| Sedationdrowsiness from a medicine | 8 | 5.1% |
| Tissue damage | 3 | 1.9% |
| Cerebrospinal fluid leakage | 1 | 0.6% |
| Extraskeletal ossification | 1 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.6% |
| Injurya physical injury | 1 | 0.6% |
| Muscle weakness/atrophy | 1 | 0.6% |
| Paralysis | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | T-Pal Spacer Applicator Handle | Product code MAX | All MAUDE reports |
|---|---|---|---|
| Reports | 157 | 9,238 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 14% | 35.6% | 36.2% |
| Classified as malfunction | 86% | 63.3% | 62.3% |
| Filed by the manufacturer | 100% | 97.1% | 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 MAX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Catalyft PL Expandable Interbody System | 378 | 95 | 0% |
| ELEVATE Spinal System | 386 | 46 | 0% |
| CAPSTONE Spinal System | 358 | 26 | 0.3% |
| Crescent Spinal System | 322 | 5 | 0.6% |
| Clydesdale Spinal System | 260 | 33 | 0.4% |
| CLYDESDALE PTC Spinal System | 222 | 5 | 0% |
| Pivox Oblique Lateral Spinal System | 255 | 5 | 0% |
| T-Pal Spacer Applicator Inner Shaft | 271 | 0 | 0% |
| T-Pal Spacer Applicator Knob | 185 | 0 | 0% |
| Unknown Cage/Spacer | 280 | 4 | 0% |
| Unknown_Spine_Product | 596 | 24 | 0% |
| Orthopedic Manual Surgical Instrument | 1,143 | 0 | 0.2% |
| Collect No Qas Spine Anterior Stabilis | 269 | 0 | 0% |
| Verte-Stack Spinal System | 212 | 0 | 0.5% |
| Divergence Anterior Cervical Fusion System | 230 | 30 | 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 T-Pal Spacer Applicator Handle reports
How many FDA reports name T-Pal Spacer Applicator Handle?
157 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 (86%) and injury (14%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical jam (26.1%), fitting problem (18.5%), device operates differently than expected (15.9%), device-device incompatibility (10.8%) and break (7.6%). 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 T-Pal Spacer Applicator Handle 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.