MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2013-08-23 for manufactured by Synthes Usa.
[3712969]
((b)(4) study patient) a report was received regarding a (b)(4) study patient who returned to the study site on (b)(6) 2012 complaining of back pain in and around the surgical site and off the sides. The patient had been previously experiencing back pain for greater than a year and was subsequently implanted on (b)(6) 2011 with 1 chronos strip, 5cc bma, and 3. 75cc local bone at l5-s1 and unspecified matrix construct. Prior to implantation, the patient was treated with nsaids and injections. Upon examination, the investigator determined that back pain was clearly not related to the device, but possibly related to the surgery. The investigator also reported the severity of the event to be moderate with some limitation of usual activities. Subsequently, the patient symptoms were noted as improving. This report is for 4 unknown pedicle screws. This is report 2 of 4 for complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11019048]
Device was used for treatment, not diagnosis. Patient identifier (b)(6). 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 | 2520274-2013-05269 |
| MDR Report Key | 3305799 |
| Report Source | 02,05 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-07-26 |
| Date Mfgr Received | 2013-07-26 |
| Date Added to Maude | 2013-08-23 |
| 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 | BRYAN WRIGHT |
| 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 | 2013-08-23 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-23 |