MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2017-03-26 for SHILLA GROWTH GUIDANCE SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[70860544]
Common device name: stabilization or correction of spinal deformities without the use of fusion. (b)(4). 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
[70860545]
It was reported that on: (b)(6) 2015: the device was implanted in patient. On (b)(6) 2016: the patient presented for follow-up visit at 18 months? No issues found radiographically (b)(6) 2016: the patient fell off a jungle gym and hit hard on the right shoulder. For complaint of pain, the patient saw a doctor in the neighborhood and was diagnosed with fracture at right shoulder under radiographic images. On (b)(6) 2016: the patient underwent radiographic exam and no loosening or migration of implant was observed. The patient also did not complaint of peri-implant pain. On (b)(6) 2017: the patient presented for follow-up visit at 24 months. The patient underwent radiographic exam in which rod fracture was observed in the left-side t11-12. The patient's family told that incident which might result in the rod fracture was not noticed (after previous visit). Until today, the patient has not complained of numbness or pain at the site. On (b)(6) 2017: re-operation is planned to replace the implant.
Patient Sequence No: 1, Text Type: D, B5
[71610921]
Additional information: image review: "long segment thoraco lumbar fixation shows a paucity of hardware at intervening thoracic level with an expected rod fracture at the thoraco lumbar junction. The rods also extend well beyond the vertebral instrumentation. Unable to assess bony fusion. Root cause:surgical technique. "
Patient Sequence No: 1, Text Type: N, H10
[100684812]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2017-00599 |
| MDR Report Key | 6434952 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2017-03-26 |
| Date of Report | 2017-03-28 |
| Date Mfgr Received | 2017-03-28 |
| Date Added to Maude | 2017-03-26 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2017-03-26 |
| 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 | 2017-03-26 |