MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-02-25 for SYNERGY SPINAL SYSTEM 6005 manufactured by Interpore Cross Intl..
[19495595]
Pt originally had surgery in 2003. Post-op x-rays indicated that the rod had slipped. A second surgery was required in 2004 to replace the rods and loose cap nuts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029012-2004-00008 |
| MDR Report Key | 513077 |
| Report Source | 00 |
| Date Received | 2004-02-25 |
| Date of Report | 2004-02-25 |
| Date of Event | 2004-01-14 |
| Date Mfgr Received | 2004-01-26 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2004-02-27 |
| 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 | CAROL BERARD |
| Manufacturer Street | 181 TECHNOLOGY DRIVE |
| 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 | KWO |
| Date Received | 2004-02-25 |
| Returned To Mfg | 2004-01-26 |
| Model Number | NA |
| Catalog Number | 6005 |
| Lot Number | 31293 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 502087 |
| Manufacturer | INTERPORE CROSS INTL. |
| Manufacturer Address | 181 TECHNOLOGY DR. IRVINE CA 926182402 US |
| Baseline Brand Name | TI SYNERGY RODS |
| Baseline Generic Name | ORTHOPEDIC IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | 6005 |
| Baseline ID | NA |
| Baseline Device Family | SYNERGY SPINAL SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950709 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-02-25 |