MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-13 for REX REHAB 102799 manufactured by Rex Bionics Ltd.
[49495780]
Two engineers went on-site to perform a preliminary investigation on the rex prior to shipping back to the manufacturing facility on 3rd may 2016. No abnormalities noted. Detailed analysis of the rex at the manufacturing facility found no abnormalities. The rex was operating normally and within specification. No defects were found with the device. The patient was medically cleared prior to the session by mr. (b)(6). She had a spinal cord injury (sci) and was 5 years post injury. The patient was reported to stand regularly using a standing frame and was found to have no contraindication to standing and walking although, as is typical for the sci patient group, she was found to have osteoporosis. The physiotherapists (pts) reported only two noticeable different circumstances manifested during the session, the first was that a sit-to-stand movement was aborted due to the "patient's pelvis sagging upon rising". The standing movement was cancelled and the patient was returned to a sitting positon and transferred out from the rex. The second circumstance was that the session was "stopped due to therapist's again observing anomalies in her foot position and an increase in the valgus at her right knee" at which time ankle foot orthoses (afos) were applied to the patient's ankle. The patient then continued with the session. When the session was finished, the patient transferred out of the rex into her wheelchair, and departed shortly afterwards. Upon reviewing an observer's video of the first sit-to-stand movement, the following were noted: the heel stops were not secured, and when the patient had a spasm, she inadvertently kicked the heel stops back, and was not noticed by the supervising pts. This resulted in misaligned ankles and knees and is a likely contributing factor. Two ankle braces were used to support the user's ankles. These were found to restrict the range of motion such that the user no longer met the required range of motion specified in the instructions for use. This is a likely contributing factor. The failure investigation concluded that the most likely contributors to the injuries are as follows: on the first sit to stand movement, the patient had a spasm that caused her legs to kick back against the heel stops. Failure to securely tighten the heel stops allowed her ankles to move out of alignment, which pulled the knee and hip joints out of alignment as well. The final position of the knees and ankles in stand shows compression adequate to cause the bilateral symmetrical fractures as identified in the patient's x-rays. This is likely the most significant contributor to the injuries observed. The patient's osteoporosis was a major contributing factor to the injuries sustained. The application of afos of the type used that restrict the user's range of motion to less than that required by a rex would have caused a misalignment of the forces normally experienced in a walking pattern. This misalignment would most likely have caused stress on the user's joints and long bones, this coupled with the osteoporotic nature of the user's bone structures is a likely contributing factor to the injuries observed. The incorrect harness fitment on the first sit to stand movement is a possible contributing factor, but is unlikely to be significant in terms of the injury as the cuffs and straps appeared to be correctly fitted. Proposed recall action is to send a field safety notification to all customers. The goal is to reinforce instructions already in the ifu for securing heel stops, and for the supervising clinician to take additional care when using afos that may restrict the user's range of motion to less than that required by rex. The proposed field safety notification is attached.
Patient Sequence No: 1, Text Type: N, H10
[49495781]
User was put into the rex at approx 2. 30pm, strapped in to the device and performed a stand action. The supervising physiotherapists noticed the harness was not supporting her, so the patient was brought back to a sit position. The harness was adjusted and the patient continued with the session. The supervising physiotherapists then noted her knees and ankles did not "look good". The patient was returned to a sit position, and adaptations made and additional supports were used for the ankles. Patient then continued with the session. When taken out of rex, no swelling was noted by the supervising physiotherapists. The patient sent a text message at 8:00pm on the same day to say ankles and knees were swollen. An appointment with dr (b)(6) was organised for the following day. The patient went into bsu outpatient clinic to see dr raj and after x-rays were taken, fractures were identified. The patient was admitted to the ward.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010365481-2016-00001 |
| MDR Report Key | 5793129 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-13 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-05-05 |
| Device Manufacturer Date | 2016-03-09 |
| Date Added to Maude | 2016-07-13 |
| 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 | MR JIVA MUTHU |
| Manufacturer Street | 58 APOLLO DRIVE |
| Manufacturer City | ROSEDALE, AUCKLAND 0632 |
| Manufacturer Country | NZ |
| Manufacturer Postal | 0632 |
| Manufacturer Phone | 9 4409741 |
| Manufacturer G1 | REX BIONICS LTD |
| Manufacturer Street | 58 APOLLO DRIVE |
| Manufacturer City | ROSEDALE, AUCKLAND 0632 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 0632 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REX REHAB |
| Generic Name | REX REHAB |
| Product Code | BXB |
| Date Received | 2016-07-13 |
| Returned To Mfg | 2016-05-09 |
| Model Number | REX REHAB |
| Catalog Number | 102799 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REX BIONICS LTD |
| Manufacturer Address | 58 APOLLO DRIVE ROSEDALE, AUCKLAND 0632 NZ 0632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-07-13 |