MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-22 for SILICONE MCP SZ 10 SMCP-500-10-WW manufactured by Ascension Orthopedics.
[83238497]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[83238498]
This is 2 of 4 reports. Other mfg report numbers: 1651501-2017-00033, 1651501-2017-00035, 1651501-2017-00036. It was reported that the initial silicone mcp arthroplasty was performed on (b)(6) 2016. Revision case was scheduled for (b)(6) 2017; once the surgeon noticed that the index finger of the implants had failed, he decided to check all of the other implants (middle finger, ring finger, & small finger) had also failed or almost failed. The index finger silicone implant had broken at the hinge/distal stem of the size 20 implant. This happened as well to the middle finger size 20 implant. The size 10 ring finger implant had not completely failed but it had a visible cut at the hinge/distal stem section. The size 10 small finger implant failed in the same fashion.
Patient Sequence No: 1, Text Type: D, B5
[113778354]
Additional information received on september 12, 2017: (investigation remains unchanged) the reason for the initial implantation on (b)(6) 2016 is unknown. Reason for revision surgery: the patient was experiencing some pain and discomfort in the 6 months to 1 year time frame from the initial implantation. The patient does not have any degenerative diseases nor were they using their hand in an excessive way. The surgeon is still unsure as to why the implants failed initially.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2017-00034 |
| MDR Report Key | 6810376 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-04 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-08-22 |
| 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 | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE MCP SZ 10 |
| Generic Name | SILICONE MCP |
| Product Code | KYJ |
| Date Received | 2017-08-22 |
| Returned To Mfg | 2017-08-30 |
| Catalog Number | SMCP-500-10-WW |
| Lot Number | 152843T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-22 |