FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON
MDR report key: 5231940
·
Received November 18, 2015
Report
- Report Number
- 1030489-2015-03071
- Event Type
- Malfunction
- Date Received
- November 18, 2015
- Date of Event
- June 2, 2015
- Report Date
- November 6, 2015
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- KWP
- PMA / PMN Number
- K052187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT, THE PATIENT UNDERWENT SURGERY DUE TO FRACTURE. DURING THE SURGERY, THERE WAS ONE SET SCREW FOUND SLIPPED AND COULD NOT BE USED ANYMORE. THE SURGEON HAD TO USE ANOTHER PRODUCT TO COMPLETE THE SURGERY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 762916 | CD HORIZON | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MDT SOFAMOR DANEK PUERTO RICO MFG | NA | H5109803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR |