MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-12-22 for SHILLA GROWTH GUIDANCE SYSTEM 7674500 manufactured by Medtronic Sofamor Danek Usa, Inc.
[5142899]
It was reported that the patient underwent a posterior spinal surgical procedure at t3-l4. Sometime post-op it was found that the rod was broken and the patient reported having pain. A revision surgery was performed to replace the broken rod with larger 5. 5 diameter rod. No additional patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[12622424]
(b)(4): neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[38345575]
Macroscopic examination confirms rod is broken. Microscopic examination of the fracture surface reveals a quasi-brittle fracture, with ray-like features emanating from the area of initial crack propagation through the initial ~30% of the cross sectional area, followed by convex striations and beach marks around the middle of the fracture surface through the next ~60% until subsequent mechanical failure of the rod. Visual and microscopic examination of the outer diameter of the rod did not identify defects on the adjacent surface of the rod near the fracture initiation point that could contribute to crack propagation. Dimensional inspection confirms diameter to be within print specification. After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implant or associated components; unable to determine root cause of the foregoing event from the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-04809 |
| MDR Report Key | 4350902 |
| Report Source | 05,07 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-12-03 |
| Date Mfgr Received | 2015-03-12 |
| Date Added to Maude | 2014-12-22 |
| 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 | 2014-12-22 |
| Returned To Mfg | 2014-12-05 |
| Model Number | NA |
| Catalog Number | 7674500 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2014-12-22 |