MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-06-30 for SYNERGY SPINAL SYSTEM SEE ATTACHMENT manufactured by Interpore Cross Intl..
[16149639]
Difficulties were experienced during surgery, as screws would not seat properly onto the seat. Excess force was applied in order to assemble the implants together. There was no pt harm or injury and the case was completed unventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029012-2005-00032 |
| MDR Report Key | 618635 |
| Report Source | 05,07 |
| Date Received | 2005-06-30 |
| Date of Report | 2005-06-30 |
| Date of Event | 2005-06-02 |
| Date Added to Maude | 2005-07-05 |
| 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 | 0 |
| Manufacturer Contact | MARY CARVAJAL |
| Manufacturer Street | 181 TECHNOLOGY DR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494533200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGY SPINAL SYSTEM |
| Generic Name | ORTHOPEDIC IMPLANT |
| Product Code | JDK |
| Date Received | 2005-06-30 |
| Model Number | NA |
| Catalog Number | SEE ATTACHMENT |
| Lot Number | SEE ATTACHMENT |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 608322 |
| Manufacturer | INTERPORE CROSS INTL. |
| Manufacturer Address | * IRVINE CA * US |
| Baseline Brand Name | BIOPLEX C IMPLANT |
| Baseline Generic Name | CEMENT RESTRICTOR |
| Baseline Model No | NA |
| Baseline Catalog No | SEE ATTACHMENT |
| Baseline ID | NA |
| Baseline Device Family | SEE ATTACHMENT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K023908 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2005-06-30 |