FDA Adverse Event
Injury
Summary report: N
UNKNOWN_SPINE_PRODUCT
MDR report key: 19135980
·
Received April 18, 2024
Report
- Report Number
- 3004024955-2024-00006
- Event Type
- Injury
- Date Received
- April 18, 2024
- Date of Event
- April 3, 2024
- Report Date
- June 30, 2024
- Manufacturer
- STRYKER SPINE-US
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT: DEVICE REMAINS IMPLANTED.
Additional Manufacturer Narrative · 0
CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 0
A PATIENT REPORTED BEING DIAGNOSED WITH A TITANIUM ALLERGY AFTER BEING IMPLANTED WITH A TITANIUM IMPLANT IN THEIR CERVICAL SPINE; IT IS NOT KNOWN IF THE IMPLANT IN QUESTION IS A STRYKER DEVICE.
Description of Event or Problem · 0
A PATIENT REPORTED BEING DIAGNOSED WITH A TITANIUM ALLERGY AFTER BEING IMPLANTED WITH A TITANIUM IMPLANT IN THEIR CERVICAL SPINE; IT IS NOT KNOWN IF THE IMPLANT IN QUESTION IS A STRYKER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2309640 | UNKNOWN_SPINE_PRODUCT | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | STRYKER SPINE-US | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |