Devices › Fastener, fixation, nondegradable, soft tissue
Device brand name · Soft-tissue anchor bioabsorbable
Truespan 12 Degree Peek: medical device reports filed with FDA
1,400 reports name it, 2017–2026. Manufacturer given most often on reports: Medos International S Rl. Product code MBI.
- 1,400
- device reports naming the brand
- 0% of all MAUDE reports · about 159 a year
- 127
- reports, 12 months to August 2026
- 219 in the 12 months before
- 96.2%
- classified as malfunction
- 75.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,400 medical device reports received by FDA name the brand "Truespan 12 Degree Peek" (soft-tissue anchor bioabsorbable); the manufacturer given most often on reports is Medos International S Rl; received from September 2017 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
127 reports arrived in the 12 months to August 2026, down 42% from 219 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 (96.2%) and injury (3.8%); across all fastener, fixation, nondegradable, soft tissue reports (product code MBI) death is recorded in 0% and malfunction in 75.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device-device incompatibility (39.2%), break (18.2%) and premature activation (8.4%). The patient problems coded most often are not applicable, foreign body in patient 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 25,935 reports carrying product code MBI. 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 |
|---|---|---|---|
| Device-device incompatibility | 549 | 39.2% | 7.7% |
| Breakthe device broke | 255 | 18.2% | 33.6% |
| Premature activation | 117 | 8.4% | 2.5% |
| Positioning failure | 93 | 6.6% | 2.5% |
| Mechanical jam | 80 | 5.7% | 1% |
| Migrationthe device moved from where it was placed | 72 | 5.1% | 1.9% |
| Difficult to advance | 69 | 4.9% | 1.7% |
| Detachment of device or device componentpart of the device came off | 60 | 4.3% | 3.1% |
| Physical resistance/sticking | 44 | 3.1% | 1.8% |
| Migration or expulsion of device | 43 | 3.1% | 1.9% |
| Crackthe device cracked | 37 | 2.6% | 0.8% |
| Activation, positioning or separation problem | 25 | 1.8% | 0.7% |
| Material deformation | 25 | 1.8% | 1.4% |
| Unintended movement | 20 | 1.4% | 0.5% |
| Failure to advance | 15 | 1.1% | 1.4% |
| Device damaged prior to usethe device was damaged before use | 14 | 1% | 0.2% |
| Material split, cut or torn | 14 | 1% | 2.7% |
| Material twisted/bent | 14 | 1% | 1.4% |
| Loose or intermittent connection | 11 | 0.8% | 0.4% |
| Component misassembled | 6 | 0.4% | 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 |
|---|---|---|
| Not applicable | 140 | 10% |
| Foreign body in patientpart of a device left in the patient | 19 | 1.4% |
| Tissue damage | 13 | 0.9% |
| No patient involvement | 5 | 0.4% |
| Injurya physical injury | 3 | 0.2% |
| Needle stick/puncture | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Truespan 12 Degree Peek | Product code MBI | All MAUDE reports |
|---|---|---|---|
| Reports | 1,400 | 25,935 | 26,136,888 |
| Share of that pool | — | 5.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 3.8% | 23.7% | 36.2% |
| Classified as malfunction | 96.2% | 75.6% | 62.3% |
| Filed by the manufacturer | 100% | 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 MBI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Truespan 24 Degree Peek | 1,113 | 149 | 0% |
| Footprint Ultra Pk Suture Anchor 4 5 | 934 | 147 | 0% |
| KL 1.8 FiberTak, Shoulder | 682 | 222 | 0% |
| Rgdloop Adjustable Stnd | 519 | 81 | 0% |
| Twinfix Ultra Pk 4 5mm W/2 Ub -Wht &bl | 490 | 59 | 0% |
| Juggerstitch Curved Implant | 434 | 46 | 0% |
| Fibertak | 419 | 25 | 0% |
| Healicoil Knotless Pk Nst | 480 | 140 | 0% |
| Truespan Orthocord | 384 | 381 | 0% |
| Truespan 24 Degree Plga | 372 | 56 | 0% |
| Bone Anchor System For Soft Tissue Support | 331 | 0 | 0% |
| Omnispan Meniscal Repair 27deg | 714 | 161 | 0% |
| Truespan 12 Degree Plga | 320 | 65 | 0% |
| Truespan Meniscal Repair System Peek 12 Degree | 299 | 0 | 0% |
| Footprint Ultra Pk Suture Anchor 5 5 | 266 | 46 | 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 Truespan 12 Degree Peek reports
How many FDA reports name Truespan 12 Degree Peek?
1,400 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 127 in the latest 12 months.
What kinds of events are reported?
malfunction (96.2%) and injury (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device-device incompatibility (39.2%), break (18.2%), premature activation (8.4%), positioning failure (6.6%) and mechanical jam (5.7%). 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 Truespan 12 Degree Peek 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.