MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-12-21 for MCP SZ. 20 DISTAL WW MCP-100-20D-WW manufactured by Ascension Orthopedics.
[33969267]
Integra has completed their internal investigation on 16dec2015. The investigation included: methods: -review of device history records. -review of complaint history. Results: the review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect. Complaints related to difficulty implanting devices as well as implant fit, difficulty removing implants, and intra-op/post-op implant fractures were included for trending, resulting in 35 complaints reported during the last 5 years. During the last 5 years, there have been (b)(4) units sold. The resulting overall rate of complaints is (b)(4). A negative yearly trend has not been identified, but since the reported complaints included adverse events with serious severity ratings, it is considered an adverse trend. Conclusion: the implants or trials were not returned; therefore, a root cause could not be identified at this time.
Patient Sequence No: 1, Text Type: N, H10
[33969268]
It was reported there was a discrepancy with sizing of trial vs implant devices. When the set was returned to the distributor, the hospital indicated that the trial implants are smaller than the real implant (same size indicated but different size in reality). The hospital thought that trial implants are perhaps used. When the set was received, the distributor checked the trial implants. They are correct not damaged and not broken. The distributor thought that perhaps the "real" implanted implants have not the correct size/dimensions. It was later reported that the surgery could be finished. The surgeon had difficulties regarding the difference between size of final implants and trial implants. The patient was not directly impacted by this matter but the surgeon had to adapt to the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2015-00045 |
| MDR Report Key | 5313452 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-12-21 |
| Date of Report | 2015-11-26 |
| Date Mfgr Received | 2015-11-26 |
| Device Manufacturer Date | 2014-07-30 |
| Date Added to Maude | 2015-12-21 |
| 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 MARIA LEONARD |
| 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. 20 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2015-12-21 |
| Catalog Number | MCP-100-20D-WW |
| Lot Number | 141914T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-12-21 |