MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-09-11 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[86008438]
Investigation completed 09/05/2017. The device history record for product id 10244 lot code 151. The devices manufactured during this period passed all required inspection points with no associated mrr? S, variances or rework. Service history: previous repairs. The weld has broken loose on the subassembly. Failure analysis to determine root cause confirmed complaint event. Device received with broken clamp. General maintenance needed. The most likely root cause is over tightening the clamp handle.
Patient Sequence No: 1, Text Type: N, H10
[86008439]
Omni post when locked in position with the arm attached is moving on the post when the surgeon is working. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125289-2017-00013 |
| MDR Report Key | 6855479 |
| Report Source | USER FACILITY |
| Date Received | 2017-09-11 |
| Date of Report | 2017-08-11 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-09-11 |
| 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 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 | OMNI-FLEX STERILE FIELD POST |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2017-09-11 |
| Catalog Number | 10244 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-09-11 |