MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-01-08 for TORNIER MTO-PS3L manufactured by Tornier Inc..
[21763090]
It is reported that a pt with a tornier foot fixation system originally implanted on (b)(6) 2008 presented for evaluation of a screw backing out of position, but was otherwise asymptomatic. It is reported that one of the fixation screws was clinically confirmed as backing out of position and also that the fixation plate had broken. The fixation system, plate and all screws, was completely removed by revision surgery on (b)(6) 2009, without device replacement required. No additional adverse pt effect, other than the revision surgical event to allow explantation, is reported to have occurred. Device serial/lot numbers have not been identified. Device return for evaluation has been requested and may occur. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610667-2010-00020 |
| MDR Report Key | 2627518 |
| Report Source | 08 |
| Date Received | 2010-01-08 |
| Date of Report | 2010-01-08 |
| Date of Event | 2009-12-17 |
| Date Mfgr Received | 2009-12-17 |
| Date Added to Maude | 2012-06-26 |
| 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 | RALPH BARISANO, VP |
| Manufacturer Street | 100 CUMMINGS CENTER SUITE 444C |
| Manufacturer City | BEVERLY MA 01915 |
| Manufacturer Country | US |
| Manufacturer Postal | 01915 |
| Manufacturer Phone | 9782329997 |
| Manufacturer G1 | TORNIER INC. |
| Manufacturer Street | 3601 W. 76TH ST SUITE 200 |
| Manufacturer City | EDINA MN 55435 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55435 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TORNIER |
| Generic Name | PLATE, FIXATION, BONE |
| Product Code | NDF |
| Date Received | 2010-01-08 |
| Catalog Number | MTO-PS3L |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC. |
| Manufacturer Address | EDINA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-01-08 |