VERTEX RECONSTRUCTION SYSTEM
Report
- Report Number
- 1030489-2014-00490
- Event Type
- Injury
- Date Received
- February 17, 2014
- Report Date
- February 28, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THE SUSPECT DEVICE WAS NOT IDENTIFIED; THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE: G6900240, 0025947W; G6900240, 0031318W; G6945824, W07F3056; G6945826, W06K1188; G6945826, W07F3058; G6950305, 0012736W; G6950305, 0028024W. (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.
THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 6945824, 6945826, 6900240 WITH 510K # K043020 AND K123906 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G6945824 / LOT: UNKNOWN (X2) PART: G6945826 / LOT: UNKNOWN (X2) PART: G6900240 / LOT: UNKNOWN (X2) ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SURGICAL PROCEDURE AT C4-6. SOMETIME POST-OP IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENING AXIAL PAIN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100373 | VERTEX RECONSTRUCTION SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SCREWS, RODS, SETSCREWS |