FDA Adverse Event
Injury
Summary report: N
VERTEX RECONSTRUCTION SYSTEM
MDR report key: 8756698
·
Received July 3, 2019
Report
- Report Number
- 1030489-2019-00691
- Event Type
- Injury
- Date Received
- July 3, 2019
- Report Date
- July 3, 2019
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- KWP
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #6958928, 510K# K042789, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT OCCIPITO POSTERIOR CERVICAL FUSION FROM O-C7. IN WHICH, THE SCREWS HAVE BEEN IMPLANTED. POST-OP, THE SCREW ON THE RIGHT SIDE OF THE C6 LOOSENED. THE INSTABILITY DUE THIS EVENT REMAINED IN THE PATIENT. HENCE, PATIENT UNDERWENT A REVISION SURGERY FOR THE REPLACE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554165 | VERTEX RECONSTRUCTION SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |