MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-17 for SHILLA GROWTH GUIDANCE SYSTEM 7675500 manufactured by Medtronic Sofamor Danek Usa, Inc.
[80117371]
Common device name: stabilization or correction of spinal deformities without the use of fusion. (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
[80117372]
Pre-op diagnosis: early-onset scoliosis it was reported that on an unknown date the rod broke. As a result, revision surgery was performed to replace the broken rod on (b)(6) 2017. No fragments remained inside the patient.
Patient Sequence No: 1, Text Type: D, B5
[106249650]
Product analysis: microscopic examination of the fracture surface identified a fairly flat fracture, with initial gently convex progressive striations and beach marks through the cross-sectional area. With a sheer lip at the very end of the fracture. The above observations are consistent with cyclic fatigue as the mechanism of failure. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2017-01774 |
| MDR Report Key | 6716596 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-17 |
| Date of Report | 2018-04-19 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2015-08-18 |
| Date Added to Maude | 2017-07-17 |
| 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 | STACIE ZIEMBA |
| 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 | 2017-07-17 |
| Returned To Mfg | 2018-02-19 |
| Model Number | NA |
| Catalog Number | 7675500 |
| Lot Number | CA15C064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-07-17 |