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 2014-06-02 for SHILLA? GROWTH GUIDANCE SYSTEM 7674500 manufactured by Medtronic Sofamor Danek Usa, Inc.
[4659185]
It was reported that a patient underwent an unknown spinal procedure. At an unknown time post-op, it was noted that a rod was broken. A revision was done to replace the broken rod. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[11817446]
(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
[33778790]
Analysis of the returned device shows that macroscopic examination confirms rod is broken around the rod vertical mid-line. Microscopic examination of the fracture surface reveals a fairly brittle fracture, with some limited evidence of fatigue around the middle of the fracture surface, and ray-like features emanating from the area of crack propagation through the entire cross section of the rod. No defects noted 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 | 1030489-2014-02689 |
| MDR Report Key | 3843974 |
| Report Source | 01,05,07 |
| Date Received | 2014-06-02 |
| Date of Report | 2014-09-23 |
| Date of Event | 2014-03-31 |
| Date Mfgr Received | 2014-09-23 |
| Device Manufacturer Date | 2011-11-14 |
| Date Added to Maude | 2014-06-02 |
| 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 | 2014-06-02 |
| Returned To Mfg | 2014-08-21 |
| 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 | 2014-06-02 |