Device manufacturer, as written on reports
Oberdorf Synthes Produktions: medical device reports filed with FDA
17,336 reports name it as the manufacturer of the device involved, 2012–2020.
- 17,336
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 32.1%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
17,336 medical device reports received by FDA give Oberdorf Synthes Produktions as the manufacturer of the device involved, 0.1% of the MAUDE database, from April 2012 to November 2020. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
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 injury (67.7%), malfunction (32.1%) and death (0.1%). 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 |
|---|---|---|---|---|
| UNK - Screws: Trauma | Screw, fixation, bone | 762 | 288 | 0% |
| UNK - Constructs: Plate/Screws | Plate, fixation, bone | 537 | 9 | 0% |
| UNK - Screws: Locking | Screw, fixation, bone | 278 | 98 | 0% |
| Unk - Plates | Plate, fixation, bone | 276 | 0 | 0% |
| Ti Low Profile Neuro Screw Self-Drilling 4mm | Plate, bone | 173 | 4 | 0% |
| UNK - Constructs: DHS/DCS | Appliance, fixation, nail/blade/plate combination, multiple component | 156 | 17 | 1.9% |
| Unk - Screws | Screw, fixation, bone | 133 | 0 | 0% |
| Unk - Screws Cannulated | Screw, fixation, bone | 100 | 9 | 0.5% |
| Femoral Neck System Plate 1 Hole - Sterile | Appliance, fixation, nail/blade/plate combination, multiple component | 85 | 1 | 0% |
| Unk - Plates Spine | Plate, fixation, bone | 82 | 0 | 0% |
| 1 85mm Ti Matrix Screw Self-Tapping/6mm | Plate, bone | 77 | 16 | 0% |
| Unk - Nail Head Elements Pfna Blade | Rod, fixation, intramedullary and accessories | 67 | 1 | 0% |
| Vertecem V+ Cement Kit | Cement, bone, vertebroplasty | 67 | 98 | 0.1% |
| UNK - Nails: TFNA | Rod, fixation, intramedullary and accessories | 53 | 24 | 0% |
| Impactor F/Pfna Blade | Impactor | 45 | 0 | 0% |
| Synframe Ring Clamp | Orthopedic manual surgical instrument | 44 | 0 | 0% |
| UNK - Screws: CMF | Screw, fixation, bone | 44 | 280 | 0% |
| UNK - Drill Bits: Trauma | Bit, drill | 40 | 14 | 0% |
| Unk - Screws Cortex | Screw, fixation, bone | 39 | 16 | 0% |
| UNK - Guide/Compression/K-Wires | Wire, surgical | 37 | 14 | 0% |
| Unk - Constructs Pfna | Rod, fixation, intramedullary and accessories | 36 | 0 | 1.2% |
| 2 0mm Drill Bit With Depth Mark/Qc/140mm | Bit, drill | 34 | 19 | 0% |
| T-Pal Spacer Applicator Knob | Intervertebral fusion device with bone graft, lumbar | 30 | 0 | 0% |
| T-Pal Spacer Applicator Inner Shaft | Intervertebral fusion device with bone graft, lumbar | 29 | 0 | 0% |
| Unk - Nails | Rod, fixation, intramedullary and accessories | 24 | 12 | 0% |
| UNK - Nail Head Elements: TFNA Helical Blade | Rod, fixation, intramedullary and accessories | 22 | 13 | 0% |
| Inserter For Ti Elastic Nails | Orthopedic manual surgical instrument | 20 | 1 | 0% |
| Drive Shaft-Minimum 520mm Length-For Use With Ria | Reamer | 19 | 0 | 0.2% |
| Ti 12-Point Nut-11mm | Thoracolumbosacral pedicle screw system | 16 | 0 | 0% |
| 1 8mm Drill Bit With Depth Mark/Qc/110mm | Bit, drill | 14 | 10 | 0% |
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 |
|---|---|---|---|
| HWC | Screw, fixation, bone | 3,734 | 21.5% |
| HRS | Plate, fixation, bone | 2,887 | 16.7% |
| HSB | Rod, fixation, intramedullary and accessories | 1,990 | 11.5% |
| KTT | Appliance, fixation, nail/blade/plate combination, multiple component | 1,281 | 7.4% |
| LXH | Orthopedic manual surgical instrument | 700 | 4% |
| JEY | Plate, bone | 607 | 3.5% |
| HTW | Bit, drill | 599 | 3.5% |
| HXX | Screwdriver | 490 | 2.8% |
| FZX | Guide, surgical, instrument | 266 | 1.5% |
| MNH | Orthosis, spondylolisthesis spinal fixation | 247 | 1.4% |
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 Oberdorf Synthes Produktions reports
How many FDA device reports name Oberdorf Synthes Produktions as manufacturer?
17,336 reports through August 2026, 0 of them in the latest 12 months.
Which of its brands appear most often?
UNK - Screws: Trauma (762), UNK - Constructs: Plate/Screws (537), UNK - Screws: Locking (278), Unk - Plates (276) and Ti Low Profile Neuro Screw Self-Drilling 4mm (173).
Which device types does it report on?
screw, fixation, bone (21.5%), plate, fixation, bone (16.7%), rod, fixation, intramedullary and accessories (11.5%) and appliance, fixation, nail/blade/plate combination, multiple component (7.4%).
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.