MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-16 for RE-FLEX SHOCK SSPE9300 manufactured by Ossur Hf.
[142039848]
Field safety notice was sent to the customer in (b)(6) 2015, after the device was sent out to the user (2014). The field safety notice explicitly indicates non-? Ssur componentry not to be fitted with the? Ssur devices and to torque to appropriate settings. Furthermore, the ifu explicitly indicates recommends use of? Ssur adapters. No indication of manufacturing failure was detected on the product during the analysis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142039849]
The pyramid detached from the foot as the patient was walking. Patient fell and sustained injuries to the shoulder and wrist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2019-00006 |
| MDR Report Key | 8517658 |
| Report Source | OTHER |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2019-04-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RE-FLEX SHOCK |
| Generic Name | PROSTHETIC FOOT |
| Product Code | ISH |
| Date Received | 2019-04-16 |
| Model Number | SSPE9300 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-16 |