MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for FACET SCREWS SPINE DEVICE manufactured by Interventional Spine, Inc..
[75737838]
Reporter said 2 years after he had surgery, he started having pain. He went to see a doctor and was told that the screws are broken. He said in (b)(6) 2014 they removed the top portion of the implants and left the bottom parts. He was told by his doctor that the explanted parts were sent to the mfr. The reporter contacted the mfr and found out that they never received the parts. He said the ceo of the company told him that it is unusual for the parts to break, and he told him he would file a report on his behalf. The reporter said he continued to have pain and also wondering what is in his body.
Patient Sequence No: 1, Text Type: D, B5
[93041963]
Add'l info received from reporter for report # mw5069876. Pt corrected part of address.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069876 |
| MDR Report Key | 6578014 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-18 |
| Date of Event | 2011-02-09 |
| Date Added to Maude | 2017-05-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FACET SCREWS SPINE DEVICE |
| Generic Name | FACET SCREWS SPINE DEVICE |
| Product Code | MRW |
| Date Received | 2017-05-18 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Brand Name | FACET SCREWS SPINE DEVICE |
| Generic Name | FACET SCREWS SPINE DEVICE |
| Product Code | MRW |
| Date Received | 2017-05-18 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-18 |