MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-19 for PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20 FGT-20 manufactured by Tornier Inc..
[4921523]
Possible allergy to the implant has appointment with the allergist on thursday (b)(6) 2014. Needs a sample or portion of the silicon and titanium of product that is in the fgt implant. Post op symptom: she came out of the surgery in pain (morphine was administered in the recovery room). Then pain and swelling in her foot. Swelling has reached all joints. Within 4 months of surgery, the downward progression started. Has had numerous tests done for ra, lupus, diabetes, etc. And they have all been negative.
Patient Sequence No: 1, Text Type: D, B5
[12207314]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2014-00018 |
| MDR Report Key | 4131197 |
| Report Source | 04 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-07-22 |
| Date Mfgr Received | 2014-07-22 |
| Date Added to Maude | 2014-10-01 |
| 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 Contact | KEVIN SMITH |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9524267643 |
| Manufacturer G1 | TORNIER INC. |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMUS GREAT TOE IMPLANT WITH GROMMETS SIZE 20 |
| Generic Name | NONE |
| Product Code | KWH |
| Date Received | 2014-08-19 |
| Catalog Number | FGT-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | BLOOMINGTON MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-19 |