MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-05-10 for SILC 1116.0006S manufactured by Globus Medical, Inc..
[74889214]
The bands and clamps were returned for evaluation. Upon inspection it was noted that all bands had been separated across the width and the ends had frayed. This type of band failure can only be replicated if the band has a cut or snag, and is then placed under extreme load. Evaluation of the scans provided show the clamps still in place at t8-t9 levels. It can also be noted that the screws at t10 have become loose and pulled out of the bone. It was noted that the breakage occurred in the middle of the bands, not at the clamp interface. While it is indeterminate as to the cause of the failure, it is possible the bands were nicked during insertion, frayed against hard bone, or clamp and band interference against the rod or bone. The cause of the reported issue cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[74889215]
The patient complained of pain at t8-t9. The surgeon removed the silc implants and found all four bands had broken at the middle of the lamina bands. The surgeon removed the hardware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004142400-2017-00025 |
| MDR Report Key | 6558629 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-05-10 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-04-19 |
| Date Added to Maude | 2017-05-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL PAUL |
| Manufacturer Street | 2560 GENERAL ARMISTEAD AVENUE |
| Manufacturer City | AUDUBON PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal | 19403 |
| Manufacturer Phone | 6109301800 |
| Manufacturer G1 | GLOBUS MEDICAL, INC. |
| Manufacturer Street | 2560 GENERAL ARMISTEAD AVENUE |
| Manufacturer City | AUDUBON PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILC |
| Generic Name | SILC BAND |
| Product Code | OWI |
| Date Received | 2017-05-10 |
| Returned To Mfg | 2017-04-21 |
| Model Number | 1116.0006S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBUS MEDICAL, INC. |
| Manufacturer Address | 2560 GENERAL ARMISTEAD AVENUE AUDUBON PA 19403 US 19403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-10 |