FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 6871626
·
Received September 18, 2017
Report
- Report Number
- 1030489-2017-02056
- Event Type
- Malfunction
- Date Received
- September 18, 2017
- Date of Event
- August 2, 2017
- Report Date
- August 21, 2017
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- KWP
- UDI-DI
- 00613994966476
- PMA / PMN Number
- K113174
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
PRE-OP DIAGNOSIS: TRAUMA- FRACTURE IN "LWS" AREA PROCEDURE: SUPPLY OF A TRAUMA FRACTURE IT WAS REPORTED THAT DURING SURGERY, A METAL ABRASION OCCURRED WHEN THE SET SCREW WAS SCREWED IN THE SAGITTAL ADJUSTING SCREW(SAS). NO FRAGMENT OF THE SET SCREW REMAINED IN THE PATIENT. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654253 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | UNK | 00613994966476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |