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..
[366828]
Patient 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 | 2029012-2004-00009 |
MDR Report Key | 512892 |
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 | 2002-07-01 |
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 92618 |
Manufacturer Country | CA |
Manufacturer Postal | 92618 |
Manufacturer Phone | 4533200 |
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 | 31855 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | N |
Implant Flag | Y |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 501899 |
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 |