MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02 report with the FDA on 2015-04-22 for SHILLA GROWTH GUIDANCE SYSTEM 7675030 manufactured by Medtronic Sofamor Danek Usa, Inc.
[22038003]
It was reported that the patient underwent a posterior spinal surgical procedure. Post-operatively it was noticed on x-ray that the screws were? Mislocated? At t3, l1 and l2. There was no neurological events related to the mislocation. The patient underwent a revision surgery 5 days later? Replacement cables at the vertebra of l1 and l2 screw removed. Replacement of transverse fixator from 30-34mm to 28-30mm.? The mislocated screw at t3 was not reoperated on because the investigator diagnosed that there was no neurological issue at that level.
Patient Sequence No: 1, Text Type: D, B5
[22349101]
The lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device. However, the suspect devices in use are lot # ca14f037, # ca14f094 and # ca14e042. (b)(4): manufacture date for lot ca14f037 is 10/15/2014; manufacture date for lot ca14f094 is 11/07/2014. 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
| Report Number | 1030489-2015-00831 |
| MDR Report Key | 4718092 |
| Report Source | 01,02 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-03-24 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2015-03-24 |
| Date Added to Maude | 2015-04-22 |
| 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 | 0 |
| 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 | 2015-04-22 |
| Model Number | NA |
| Catalog Number | 7675030 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-04-22 |