MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-02-28 for SCREW 9024-00 / 9045-01 manufactured by Interventional Spine, Inc..
[18836940]
Removal of 2 each bone-lok implants. Original procedure done (b)(6) 2008. Recently, the patient complained of a little pain, but last month had more leg pain. The level 3/4 placement fused; however, the 4/5 did not fuse; the physician saw subsidence creating a rocking motion. According to the physician the fusion failure was not due to isi implants, but to the anterior cages previously placed. The physician removed the implants at level 4/5; the one implant (rt side removal was fine according to (b)(6); the other was a problem, i. E. After attempting to remove for 15-20 minutes, the second implant came apart (head, washer, top sleeve. ) the physician then performed fluoro and found that the threaded portion remained in the patient. The physician didn't think it was a quality issue but due to moving around in the area. The physician did finally remove the screw from the patient.
Patient Sequence No: 1, Text Type: D, B5
[18955349]
Root cause: pain in patient was due to other product from other manufacturer. Implant came apart during removal due to stresses applied by physician. Initially it was determined the event was not reportable. On a subsequent re-review, it was determined this event should have been reported. Device evaluation: returned device was visually inspected. Implant components were reassembled and locking mechanism was tested. Locking strength met specifications. Add'l mfr date: 12/2007.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00065 |
| MDR Report Key | 2045686 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2009-01-21 |
| Date of Event | 2009-01-20 |
| Date Mfgr Received | 2009-01-21 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2012-02-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 13700 ALTON PKWY., SUITE 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREW |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | 9024-00 / 9045-01 |
| Catalog Number | 9024-00 / 9045-01 |
| Lot Number | 111207-A / 120707-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-28 |