MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-22 for MCP SZ. 30 DISTAL WW MCP-100-30D-WW manufactured by Ascension Orthopedics.
[142677752]
Dhr for lot 183077t shows that no nonconformances were generated for this lot. The root cause is unknown as the products have not been returned; however, patient activity is a possible contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[142677753]
1 of 2 reports: other mfg report number: 1651501-2019-00015. A company sales representative reported that on (b)(6) 2018 a pyrocarbon mcp (id: mcp-100-30d-ww / lot 183077t) was implanted and on (b)(6) 2019, it was removed due to breakage. The broken implant was discovered during an outpatient visit. The broken implant was replaced with a competitor device. The patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00014 |
| MDR Report Key | 8537440 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-06-25 |
| Date Added to Maude | 2019-04-22 |
| 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 VIVIAN NELSON |
| 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 | MCP SZ. 30 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2019-04-22 |
| Returned To Mfg | 2019-06-25 |
| Catalog Number | MCP-100-30D-WW |
| Lot Number | 183077T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-22 |