MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2017-01-23 for SHILLA GROWTH GUIDANCE SYSTEM 7674500 manufactured by Medtronic Sofamor Danek Usa, Inc.
[65453454]
(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.
Patient Sequence No: 1, Text Type: N, H10
[65453455]
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.
Patient Sequence No: 1, Text Type: D, B5
[99029521]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2017-00132 |
| MDR Report Key | 6269212 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2017-01-23 |
| Date of Report | 2016-12-28 |
| Date Mfgr Received | 2016-12-28 |
| Date Added to Maude | 2017-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILLA GROWTH GUIDANCE SYSTEM |
| Product Code | PGM |
| Date Received | 2017-01-23 |
| Model Number | NA |
| Catalog Number | 7674500 |
| Lot Number | CA11A055 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-23 |