MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2017-04-27 for SHILLA GROWTH GUIDANCE SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[73782319]
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. 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
[73782320]
It was reported that on (b)(6) 2017, patient's family contacted the hospital to explain the patient's situation to the doctor as follows:? The skin around the neck was swollen taking on red color and felt hard when touched, and the patient was claiming a slight pain?. As a direct examination was determined to be necessary, the visit was set on (b)(6) 2017. On (b)(6) 2017, patient's neck area was apparently swollen and hard with red color. According to her family, there had been no events such as bumps. Rod was found to be lean toward the back under x-ray images. Nesplon tether between t3 and t4 on the left was considered to be broken. Patient was hospitalized immediately based on the determination that a re-operation would be necessary within a few days. The operation was arranged for (b)(6) 2017. The surgery went well on (b)(6) 2017. It was found that vertebral arches of t3 and t4 were cut out near spinous process.
Patient Sequence No: 1, Text Type: D, B5
[100657072]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2017-01002 |
| MDR Report Key | 6525230 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-04-27 |
| Date of Report | 2017-03-28 |
| Date Mfgr Received | 2017-03-28 |
| Date Added to Maude | 2017-04-27 |
| 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 |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| 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 | 2017-04-27 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-27 |