MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2015-01-06 for BIOM T2 11-00A manufactured by Iwalk Inc..
[18027996]
User of the prosthesis (ankle/foot) reported that over a year earlier, he had fallen and broken the patella in his sound leg (the leg without the prosthesis). He reported that while pushing a heavy trash can, he stubbed the toe of the biom device which prompted it to provide power as it is designed to do on toe off, and that the powered push off put him off balance, resulting in a fall which drove his good knee into the ground, breaking the patella. User reported that the biom was not the cause of the fall leading to him breaking his patella per se, but that the power provided on the toe off contributed to him losing his balance and falling. No malfunction of the device was reported and the device has continued to function normally since the event.
Patient Sequence No: 1, Text Type: D, B5
[18132453]
The user first informed an iwalk rep of the fall on (b)(6) 2013, but made no indication that treatment was required for the inquiry or that he felt the biom was at fault at that time, and referenced the fall only to explain why he had not corresponded in some time. A year later, on (b)(6) 2014, during another check-in with the user, he then indicated that he felt biom device was a contributing factor in the fall and resulting injury to his patella the previous year. There is no indication of a malfunction, and the user has continued to use the device since the incident. Since the user indicated that the device may have contributed to a fall leading to surgical intervention, this incident is considered a reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008869754-2015-00001 |
| MDR Report Key | 4404544 |
| Report Source | 04,05 |
| Date Received | 2015-01-06 |
| Date of Report | 2014-12-09 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2014-12-09 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2015-01-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD SMITH |
| Manufacturer Street | 4 CROSBY DR |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | 7817611570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOM T2 |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXIT |
| Product Code | ISW |
| Date Received | 2015-01-06 |
| Model Number | BIOM T2 |
| Catalog Number | 11-00A |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IWALK INC. |
| Manufacturer Address | BEDFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-06 |