MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99,company representative,unk report with the FDA on 2015-03-05 for PRIMUS FLEXIBLE GREAT TOE IMPLANT, SIZE 30 FGT-30 manufactured by Tornier Inc..
[5628418]
The implant appears to have subsided/shifted "plantarly" in the toe.
Patient Sequence No: 1, Text Type: D, B5
[13049185]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
[32716607]
Repeated attempts made to surgeon and complaint reporter to obtain x-rays and additional information about the case were unsuccessful. There appears to be no defect in the device or manufacturing of the product returned. Due to an inability to obtain an x-ray or additional patient information it is not possible to determine if the original implant was seated properly in the bone. Additionally, er were unable to obtain any additional information regarding bone density or other possible contributing factors from the surgeon. Without additional information the root cause of this issue cannot be determined. This is the final report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2015-00003 |
| MDR Report Key | 4597357 |
| Report Source | 99,COMPANY REPRESENTATIVE,UNK |
| Date Received | 2015-03-05 |
| Date of Report | 2015-02-11 |
| Date Mfgr Received | 2015-02-11 |
| Date Added to Maude | 2015-04-15 |
| 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 | 3 |
| Event Location | 3 |
| 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 FLEXIBLE GREAT TOE IMPLANT, SIZE 30 |
| Generic Name | NONE |
| Product Code | KWH |
| Date Received | 2015-03-05 |
| Catalog Number | FGT-30 |
| Lot Number | CT0414140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | BLOOMINGTON MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-05 |