MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for REBOUND B-254610002 manufactured by Ossur Hf.
[118394205]
Patient outcome: developed a foot drop at the left after wearing the brace. Nerve conduction studies confirmed demyelination and axonal damage at the level of the fibular head. Improvement has been reported which gives good hope that the nerves are recovering, it is however yet unclear whether the patient will reach full recovery. Analysis: at the review in the clinic, the patient demonstrated donning of the brace. It was noticed that the brace was fitted lower and slightly rotated. Foot drop was likely caused by pressure from the cartilage protection strap on the common peroneal nerve. The rebound cartilage uses a strapping system similar to that found on the unloader oa knee products (fit, indicator, lite, original, and smart dosing). There have been no instances of similar events on any rebound cartilage or unloader oa knee products. No manufacturing failure or product malfunction could be identified. Based on information provided about brace being fitted lower and slightly rotated, root cause is thought to be due to user having incorrectly positioned brace during donning or brace may have migrated during use. As no confirmation or evidence of product malfunction could be found, no nc, capa, or field action is necessary based on the number of identified product malfunction and low occurrence rate. We will continue to monitor. No concerns or risks for users of this product in the field could be identified at this point, no corrective/preventive considered warranted at this moment. Patient had worn the brace of a few occasions prior to the foot drop occurring. This gives further reason to believe the product was fitted correctly in first instance, but that re-fitting by the patient in a later instance caused the issue. The ifu gives clear instructions, including the following: "caution the rebound? Cartilage is field adaptable to accommodate patient comfort issues. Modifications to flexion or extension stops, hinge and shell contour should only be made by the health care professional. The healthcare professional is responsible for advising patient on use of the cartilage protection strap?. " the ifu referred to is enclosed with this report. A reminder to these instructions have been provided to the healthcare professional who has fitted the brace.
Patient Sequence No: 1, Text Type: N, H10
[118394206]
Patient wore the brace for about 4. 5 hrs, using the same settings as set by clinician, and developed foot drop on the left when patient took the brace off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2018-00001 |
| MDR Report Key | 7820449 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-08-27 |
| 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 | MISS CRYSTAL SWAFFORD |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823817 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REBOUND |
| Generic Name | REBOUND CRT LEFT MEDIAL SM |
| Product Code | ITW |
| Date Received | 2018-08-27 |
| Model Number | B-254610002 |
| Lot Number | EU151515 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | 27051 TOWNE CENTRE DRIVE FOOTHILL RANCH, 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-08-27 |