Devices › Orthosis, spondylolisthesis spinal fixation
Device brand name · Creo threaded locking cap
Creo: medical device reports filed with FDA
427 reports name it, 2016–2026. Manufacturer given most often on reports: Globus Medical. Product code MNH.
- 427
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 48
- reports, 12 months to August 2026
- 47 in the 12 months before
- 92.5%
- classified as malfunction
- 35% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
427 medical device reports received by FDA name the brand "Creo" (creo threaded locking cap); the manufacturer given most often on reports is Globus Medical; received from June 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
48 reports arrived in the 12 months to August 2026, close to the 47 of 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 (92.5%), injury (7%) and death (0.2%); across all orthosis, spondylolisthesis spinal fixation reports (product code MNH) death is recorded in 0% and malfunction in 35%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are loose or intermittent connection (15.7%), migration (14.1%) and fracture (12.2%). The patient problems coded most often are spinal column injury, failure of implant and appropriate clinical signs, symptoms and conditions term/code not available. 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 4,393 reports carrying product code MNH. 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 |
|---|---|---|---|
| Loose or intermittent connection | 67 | 15.7% | 4.2% |
| Migrationthe device moved from where it was placed | 60 | 14.1% | 4.4% |
| Fracturea broken bone | 52 | 12.2% | 5% |
| Breakthe device broke | 31 | 7.3% | 21.3% |
| Insufficient device problem information | 31 | 7.3% | 6.6% |
| Human-device interface problem | 23 | 5.4% | 0.5% |
| Detachment of device or device componentpart of the device came off | 20 | 4.7% | 1.9% |
| Device dislodged or dislocated | 19 | 4.4% | 3.1% |
| Device slipped | 17 | 4% | 6.3% |
| Loosening of implant not related to bone-ingrowth | 15 | 3.5% | 1% |
| Material separation | 14 | 3.3% | 1.3% |
| Migration or expulsion of device | 8 | 1.9% | 3.2% |
| Device handling problem | 6 | 1.4% | 0.1% |
| Material fragmentation | 5 | 1.2% | 0.3% |
| Patient device interaction problem | 4 | 0.9% | 1.1% |
| Product quality problem | 4 | 0.9% | 0.2% |
| Entrapment of device | 3 | 0.7% | 0.3% |
| Loss of or failure to bond | 3 | 0.7% | 0.1% |
| Material integrity problema problem with the device material | 3 | 0.7% | 2% |
| Mechanical problema mechanical problem | 3 | 0.7% | 2.2% |
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 |
|---|---|---|
| Spinal column injury | 60 | 14.1% |
| Failure of implant | 44 | 10.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 16 | 3.7% |
| Foreign body in patientpart of a device left in the patient | 13 | 3% |
| Painpain, site not specified | 10 | 2.3% |
| Spinal cord injury | 5 | 1.2% |
| Implant pain | 3 | 0.7% |
| Bone fracture(s) | 2 | 0.5% |
| Device embedded in tissue or plaque | 2 | 0.5% |
| Falla fall | 2 | 0.5% |
| Adhesion(s) | 1 | 0.2% |
| Complaint, ill-defined | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Multiple organ dysfunction syndromeseveral organs failing | 1 | 0.2% |
| Nonunion/delayed-union bone fracture | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Creo | Product code MNH | All MAUDE reports |
|---|---|---|---|
| Reports | 427 | 4,393 | 26,136,888 |
| Share of that pool | — | 9.7% | 0% |
| Classified as death, per 1,000 reports | 2 | 0 | 9 |
| Classified as injury | 7% | 64.2% | 36.2% |
| Classified as malfunction | 92.5% | 35% | 62.3% |
| Filed by the manufacturer | 99.3% | 99.3% | 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 MNH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Screw/Rod Construct Accessories | 296 | 0 | 0% |
| Ti Collar With Grooves | 286 | 0 | 0% |
| Ti Nut 11mm Width Across Flats | 328 | 0 | 0% |
| Xia 3 Titanium Blocker | 340 | 7 | 0% |
| Unknown Screws | 652 | 23 | 1.7% |
| Unknown Mono/Polyaxial Screws | 390 | 0 | 0% |
| Ti Locking Screw | 422 | 0 | 0% |
| Unknown Rods | 183 | 9 | 1.1% |
| Verse Correction Key | 288 | 3 | 0% |
| Mis Single Inner Setscw | 209 | 9 | 0.5% |
| Unknown Cage/Spacer | 280 | 4 | 0% |
| Unknown_Spine_Product | 596 | 24 | 0% |
| Ti Matrix Locking Cap | 489 | 0 | 1.2% |
| Cd Horizon Solera 5 5/6 0 | 478 | 131 | 0% |
| UNK - Constructs: Plate/Screws | 850 | 9 | 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 Creo reports
How many FDA reports name Creo?
427 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 48 in the latest 12 months.
What kinds of events are reported?
malfunction (92.5%), injury (7%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
loose or intermittent connection (15.7%), migration (14.1%), fracture (12.2%), break (7.3%) and insufficient device problem information (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Creo 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.