MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-11-22 for manufactured by Synthes (usa).
[4084042]
It was reported that the patient had an explant and revision surgery due to a broken pedicle screw. The patient originally had a cervical fusion at t-2 in (b)(6) 2010 and ten months later, the patient returned to the surgeon? S office on an unknown date, complaining of pain. It was discovered via x-rays that a pedicle screw had broken. The surgeon removed a portion of the pedicle screw and the longer portion remains in the patient? S bone. The patient was then implanted with other unknown hardware and was fused at t-3. This report is for one unknown screw. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11293195]
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. This report is for one unknown screw/unknown lot. Implant date: unknown date (b)(6) 2010. Device was used for treatment, not diagnosis. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[26440386]
.
Patient Sequence No: 1, Text Type: N, H10
[26440387]
Patient reported that he is still in pain and takes daily pain medication. Patient also reported that he has limited range of motion and limited in the length of time he can stand or sit. Patient does not have piece of screw that was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2013-07399 |
| MDR Report Key | 3483236 |
| Report Source | 04 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-01 |
| Date Mfgr Received | 2013-12-14 |
| Date Added to Maude | 2013-11-22 |
| 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 | TRACY GUTIERREZ |
| 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 |
| Product Code | MCV |
| Date Received | 2013-11-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-22 |