FDA Adverse Event
Injury
Summary report: N
MEDTRONIC PLATE 7200060
MDR report key: 17949380
·
Received October 16, 2023
Report
- Report Number
- MW5146985
- Event Type
- Injury
- Date Received
- October 16, 2023
- Date of Event
- October 2, 2023
- Report Date
- October 13, 2023
- Manufacturer
- MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PT DIAGNOSED WITH RADICULOPATHY SECONDARY TO A CRACK IN A PREVIOUSLY PLACED GRAFT AT C6/7 AND LOOSENING OF C7 SCREW. PLATE AND SCREW WERE BOTH REMOVED, AND PROVIDER STATES CRACK IN THE GRAFT WAS CONFIRMED UPON INSPECTION. MEDTRONIC SPINE CERVICAL SCREWS AND PLATE. ITEM ID: 41818; DESCRIPTION: SCREW MEDTRONIC 3120516; NOTES: PO# 645496; MANUFACTURER: MEDTRONIC. ITEM ID: 42203; DESCRIPTION: PLATE MEDTRONIC 7200060; NOTES: PO# 645496; MANUFACTURER: MEDTRONIC. ITEM ID: 46636; DESCRIPTION: SCREW MEDTRONIC 3120415; NOTES: PO# 645496; MANUFACTURER: MEDTRONIC. REFERENCE REPORTS: MW5146984, MW5146986.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66181 | MEDTRONIC PLATE 7200060 | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | KWQ | MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Male | Hospitalization| O | MEDTRONIC SCREW 3120415| MEDTRONIC SCREW 3120516 |