MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-17 for ROD manufactured by .
[2990916]
A device report from (b)(6) indicated a hospital in (b)(6) reported: a female pt experienced a comminuted fracture of th12 due to osteoporosis. Conservative treatment was given with 3 point orthosis. The kyphosis angle changed from 6 to 16 grade with operative treatment following, date of surgery unk. Pt was treated with dorsal stabilization th11 - l1 and kyphoplasty on th12 be means of uss fracture mis hardware. It was noted after the surgery there was a minimal loss of height. The hardware has not been explanted and there are no plans to remove the hardware. No further info is available. This is 14 of 14 reports.
Patient Sequence No: 1, Text Type: D, B5
[10011227]
Without a lot number the device history records review could not be completed. The investigation could not be completed, no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-01627 |
| MDR Report Key | 2713268 |
| Report Source | 01,07 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-07-20 |
| Date Mfgr Received | 2012-07-20 |
| Date Added to Maude | 2012-12-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROD |
| Product Code | EZP |
| Date Received | 2012-08-17 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-17 |