MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-08 for STERILE FIELD POST, 1/2 10708 manufactured by Integra York, Pa Inc..
[59415286]
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
[59415287]
Customer initially reports that the two omni field posts can rotate left and right at the clamp after being locked into position (while holding the 4020 support arm. On (b)(6) 2016 customer reports an anterior lumbar interbody fusion was being performed. The issue occurred as soon as they started using the device. This is not first time use for this device. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[63926726]
On 12/1/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - both units received have rough threads on the post bolt that will need to be retapped. Both units also have bent handles on the post clamp subassemblies allowing the clamps to rotate when in the locked position. General maintenance needed. Device history evaluation - device history record reviewed for this product id show no abnormalities related to the reported failure. Passed all required inspection points with no associated mrr? S, variances or rework. No service history is on file for this device. Conclusion: in summary the end users reason for return was verified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2016-00010 |
| MDR Report Key | 6086530 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-11 |
| Date Mfgr Received | 2016-12-01 |
| Device Manufacturer Date | 2015-07-29 |
| Date Added to Maude | 2016-11-08 |
| 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 YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE FIELD POST, 1/2 |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-11-08 |
| Returned To Mfg | 2016-10-18 |
| Catalog Number | 10708 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-08 |