MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2002-11-01 for TI ROD WITH HEX 7036 manufactured by Interpore Cross International.
[19494491]
A report was received regarding a 4. 75 mm x 48 cm titanium rod with hex. It was reported that the first rod broke when the surgeon attempted to bend the rod with rod benders in situ. The surgeon removed the rod. He attempted to bend a second rod outside the surgical field at which time the rod fractured. Surgery was completed and the patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029012-2002-00014 |
| MDR Report Key | 426992 |
| Report Source | 01,08 |
| Date Received | 2002-11-01 |
| Date of Report | 2002-11-01 |
| Date of Event | 2002-01-30 |
| Date Mfgr Received | 2002-02-19 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 2002-11-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WENDY SPIELBERGER |
| 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 | TI ROD WITH HEX |
| Generic Name | ORTHOPEDIC IMPLANT |
| Product Code | KWO |
| Date Received | 2002-11-01 |
| Model Number | NA |
| Catalog Number | 7036 |
| Lot Number | 13597 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 416009 |
| Manufacturer | INTERPORE CROSS INTERNATIONAL |
| Manufacturer Address | 181 TECHNOLOGY DRIVE IRVINE CA 92618 US |
| Baseline Brand Name | TI SYNERGY RODS |
| Baseline Generic Name | ORTHOPEDIC IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | 7036 |
| 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. Other | 2002-11-01 |