MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for IMPL SYS,BIO-COMP ACHILLES SPEEDBRG AR-8928BC-CP manufactured by Arthrex, Inc..
[186328359]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[186328360]
It was reported by the patient that she had undergone a haglunds and achilles procedure on her foot on (b)(6) 2018. Her medical records note that the surgeon had implanted an arthrex speedbridge implant, ar-8928bc-cp. Patient has a known allergy to latex and surgeon also noted in her records that her implant needed to be a metal composition. Patient also disclosed that sometime in her past she has experienced issues when wearing costume jewelry and so has since avoided such jewelry. Since the surgery the patient has developed numerous issues in her foot. The foot is swollen with what appears to be a large growth. She has a stinging/ pins and needles feeling in the top of foot and has developed what looks similar to a psoriasis type outbreak on the bottom of her foot. She continually has leg cramps at night and when stepping out of bed has a tremendous amount of pain in her foot. She has undergone a year of intense therapy to help with the hypersensitivity issues she is also experiencing but although some relief the issues have continually gotten worse since the surgery. The patient has requested the material composition of the implant components which will be provided to her. The patient medical records also noted an amino tissue from active sky matrix on the tissue log indicating that she may have received some sort of tissue bank product during the surgery as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01767 |
| MDR Report Key | 9883039 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPL SYS,BIO-COMP ACHILLES SPEEDBRG |
| Generic Name | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
| Product Code | MAI |
| Date Received | 2020-03-26 |
| Model Number | IMPL SYS,BIO-COMP ACHILLES SPEEDBRG |
| Catalog Number | AR-8928BC-CP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |