MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-05-02 for SHILLA? GROWTH GUIDANCE SYSTEM 7674500 manufactured by Medtronic Sofamor Danek Usa, Inc.
[4362931]
It was reported that a scoliosis patient underwent an unknown spinal procedure from t3-l4. At an unknown time post-op, it was reported that a rod was broken. A revision surgery was done to explant and replace the broken rod. No further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
[11884356]
(b)(4): neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[30887873]
Analysis of the returned device shows that visual review confirms rod breakage. Microscopic examination of the fracture surface identified beach marks and progressive striations, which are indicative of cyclic fatigue. Dimensional inspection rod diameter confirms conformance to print specification. Multiple sub-critical cracks are noted near the fracture surface, which suggest very level of loading in this region. No material damage noted on adjacent surface to crack propagation which could contribute to crack propagation. After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implant. The above observations are consistent with cyclic fatigue.
Patient Sequence No: 1, Text Type: N, H10
[32684897]
A review of radiographic images show that this is a case involving an ehlers-danlos patient who are typically very flexible creating extreme stress on the rods. The construct is left long proximally, but is otherwise in satisfactory position. The preoperative curve is extreme both in scoliosis and kyphosis. Subsequent films show fracture of both rods at the thoracolumbar junction with recurrence of kyphosis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-02396 |
| MDR Report Key | 3786268 |
| Report Source | 01,05,07 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-07-21 |
| Date Mfgr Received | 2014-07-21 |
| Device Manufacturer Date | 2011-11-14 |
| Date Added to Maude | 2014-05-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| 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 | 2014-05-02 |
| Returned To Mfg | 2014-06-13 |
| Catalog Number | 7674500 |
| Lot Number | CA11D020 |
| 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 SWINNEA RD. MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-02 |