MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-18 for STANDARD WISHBONE ASSEMBLY 4020 manufactured by Integra Lifesciences Corporation Oh/usa.
[73096853]
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
[73096854]
Customer initially reports the arms are not holding into place when locked down. On (b)(6) 2017 customer reports the event occurred during an intralumbar interbody fusion. They noticed when placing the device that it wasn't going to hold.
Patient Sequence No: 1, Text Type: D, B5
[75252057]
On 05/02/17 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the device was not released for evaluation therefore failure analysis could not be determined. Device history evaluation - a dhr review cannot be performed at this time as the lot number as provided is not traceable. Conclusion: the device was not released for evaluation therefore the root cause to the end users experience could not be determined. This complaint will be reopened should we receive product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2017-00007 |
| MDR Report Key | 6501592 |
| Report Source | USER FACILITY |
| Date Received | 2017-04-18 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-04-18 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD WISHBONE ASSEMBLY |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2017-04-18 |
| Catalog Number | 4020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-18 |