Device manufacturer, as written on reports
Mdt Puerto Rico Operations Med Rel: medical device reports filed with FDA
1,771 reports name it as the manufacturer of the device involved, 2006–2026.
- 1,771
- reports naming it as manufacturer
- 0% of all MAUDE reports
- 523
- reports, 12 months to August 2026
- 105 in the 12 months before
- 40.1%
- classified as malfunction
- 62.3% across all reports
- 3.1%
- classified as death, as reported
- 0.9% across all reports
1,771 medical device reports received by FDA give Mdt Puerto Rico Operations Med Rel as the manufacturer of the device involved, 0% of the MAUDE database, from August 2006 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
523 reports arrived in the 12 months to August 2026, up 398% from 105 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 injury (56.7%), malfunction (40.1%) and death (3.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Synergy | Coronary drug-eluting stent | 290 | 84 | 3.5% |
| CD HORIZON Spinal System | Appliance, fixation, spinal interlaminal | 235 | 634 | 0.3% |
| Itrel 3 | Stimulator, spinal-cord, totally implanted for pain relief | 155 | 10 | 1.4% |
| Soletra | Stimulator, electrical, implanted, for parkinsonian tremor | 102 | 12 | 4.2% |
| Catalyft PL Expandable Interbody System | Intervertebral fusion device with bone graft, lumbar | 57 | 95 | 0% |
| CD HORIZON SOLERA VOYAGER Spinal System | Thoracolumbosacral pedicle screw system | 48 | 216 | 0.1% |
| Interstim | Stimulator, electrical, implantable, for incontinence | 29 | 1,522 | 0.2% |
| INFINITY Occipitocervical Upper Thoracic System | Appliance, fixation, spinal interlaminal | 27 | 19 | 0% |
| CD HORIZON SOLERA Spinal System | Thoracolumbosacral pedicle screw system | 21 | 68 | 0% |
| Cd Horizon | Appliance, fixation, spinal interlaminal | 15 | 38 | 0.3% |
| ATLANTIS Anterior Cervical Plate System | Appliance, fixation, spinal intervertebral body | 14 | 18 | 1.6% |
| Marquis Vr | Implantable cardioverter defibrillator (non-crt) | 12 | 0 | 4.8% |
| Zevo Anterior Cervical Plate System | Appliance, fixation, spinal intervertebral body | 12 | 13 | 0.6% |
| Sigma 100 Vvi | Implantable pacemaker pulse-generator | 9 | 0 | 1.4% |
| Enterra | Intestinal stimulator | 8 | 0 | 0.8% |
| Kinetra | Stimulator, electrical, implanted, for parkinsonian tremor | 7 | 1 | 2.1% |
| Enpulse | Implantable pacemaker pulse-generator | 6 | 3 | 10.4% |
| Synergy Versitrel | Stimulator, spinal-cord, totally implanted for pain relief | 6 | 4 | 0% |
| Venture Anterior Cervical Plate System | Appliance, fixation, spinal intervertebral body | 6 | 4 | 0.5% |
| Vertex Reconstruction System | Appliance, fixation, spinal interlaminal | 6 | 9 | 0.3% |
| Adapta | Pulse generator, permanent, implantable | 5 | 279 | 7.4% |
| Infinity | Implant, endosseous, root-form | 5 | 24 | 2.1% |
| Sigma 100 S | Implantable pacemaker pulse-generator | 5 | 0 | 1.8% |
| Micro Jewel | Implantable cardioverter defibrillator (non-crt) | 4 | 0 | 1.6% |
| Consulta Crt-D | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 3 | 0 | 5.9% |
| Divergence Anterior Cervical Fusion System | Intervertebral fusion device with integrated fixation, cervical | 3 | 30 | 0% |
| Enrhythm | Pulse generator, permanent, implantable | 3 | 0 | 9.9% |
| Synchromed El | Pump, infusion, implanted, programmable | 3 | 2 | 4.9% |
| Virtuoso | Implantable cardioverter defibrillator (non-crt) | 3 | 0 | 2.7% |
| Entrust | Implantable cardioverter defibrillator (non-crt) | 2 | 0 | 1.8% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| LGW | Stimulator, spinal-cord, totally implanted for pain relief | 484 | 27.3% |
| NKB | Thoracolumbosacral pedicle screw system | 276 | 15.6% |
| NVZ | Pulse generator, permanent, implantable | 233 | 13.2% |
| KWP | Appliance, fixation, spinal interlaminal | 228 | 12.9% |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | 122 | 6.9% |
| DXY | Implantable pacemaker pulse-generator | 108 | 6.1% |
| MAX | Intervertebral fusion device with bone graft, lumbar | 70 | 4% |
| LWS | Implantable cardioverter defibrillator (non-crt) | 64 | 3.6% |
| PML | Bone cement, posterior screw augmentation | 38 | 2.1% |
| EZW | Stimulator, electrical, implantable, for incontinence | 30 | 1.7% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Mdt Puerto Rico Operations Med Rel reports
How many FDA device reports name Mdt Puerto Rico Operations Med Rel as manufacturer?
1,771 reports through August 2026, 523 of them in the latest 12 months.
Which of its brands appear most often?
Synergy (290), CD HORIZON Spinal System (235), Itrel 3 (155), Soletra (102) and Catalyft PL Expandable Interbody System (57).
Which device types does it report on?
stimulator, spinal-cord, totally implanted for pain relief (27.3%), thoracolumbosacral pedicle screw system (15.6%), pulse generator, permanent, implantable (13.2%) and appliance, fixation, spinal interlaminal (12.9%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.