N
Patient 1
(B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.
MAUDE MDR 6269212
- MDR report key
- 6269212
- Report number
- 1030489-2017-00132
- Event key
- 0
- Event type
- 3
- Date received
- 2017-01-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- GREG ANGLIN
- Address
- 1800 PYRAMID PLACE MEMPHIS TN 38132 US
- Phone
- 901-901-9013
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SHILLA GROWTH GUIDANCE SYSTEM | MEDTRONIC SOFAMOR DANEK USA, INC | PGM | NA | 7674500 | CA11A055 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF ROD ON (B)(6) 2016. ON (B)(6) 2016, NO ABNORMALITY WAS SEEN BY X-RAY EXAMINATION. ROD FRACTURE AT T11 AND T12 OF LEFT SIDE WAS OBSERVED IN PATIENT IN A X-RAY EXAMINATION PERFORMED ON (B)(6) 2016. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT UNDERWENT A REVISION SURGERY FOR REPLACEMENT OF THE BROKEN ROD.
N
Patient 1
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.