MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2011-02-28 for PERPOS PLS 9045-02 manufactured by Interventional Spine Inc..
[1954212]
Pt was complaining of numbness in the left foot after a bilateral at l5-s1.
Patient Sequence No: 1, Text Type: D, B5
[9036056]
Investigation: review of ct images on cd provided by surgeon. Recent placement of trufuse devices bilaterally at l5-s1 that were subsequently replaced with bilateral perpos devices. Ct scans dated (b)(6)-2008. Comparable axial, sagittal and coronal images from both scans were reviewed and compared. Perpos devices are present bilaterally at l5-s1. Each device traverses the facet joint at l5-s1 and enters the pedicle of the sacral ala. The collar of each device is immediately adjacent to the l5 iap. The position of each device is unchanged on the two exams. The tip position of the right and left device are different from each other but stable on the two exams. On the left, there is a foreign body in the soft tissues adjacent to the l5-s1 facet joint. The density is similar to cortical bone. The implants are not related to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00017 |
| MDR Report Key | 2011906 |
| Report Source | 07,08 |
| Date Received | 2011-02-28 |
| Date of Report | 2011-02-10 |
| Date of Event | 2008-01-18 |
| Date Mfgr Received | 2008-02-27 |
| Date Added to Maude | 2012-05-24 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERPOS PLS |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | 9045-02 |
| Catalog Number | 9045-02 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2011-02-28 |