DIPLOMAT
SIGNUS Medizintechnik GmbH · Model Pedicle screw, fenestrated, reduction, monoaxial · UDI-DI 04047844023716
Description
The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | XTANT Medical Holdings, Inc | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2018-07-05 | CTL Medical Corporation | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
| 2017-06-21 | Valorem Surgical LLC | Devices are not consistent with Quality System Requirements. |
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