MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2006-02-24 for POLY-TAPE OR LEEDS-KEIO CTP 50X500MM 102-1015 manufactured by Xiros Plc.
[404329]
An orthopaedic surgeon has told co about a series of innovative procedures he conducted starting some years ago on polio patients for the flail foot condition. He used 50mm wide implantable polyester tapes provided by xiros plc. The procedure is not one that co includes in co's indications for use. Five patients in the series developed non-healing tape. The reported problems do not relate to a device covered by either 510(k) because it is outside the permitted size range, nor to either set of indications for use. In the reported procedure, the tape is used more as a supplementary artificial ligament (bone to bone) than soft tissue to bone attachment. However co believes that the product is so similar to poly-tapes covered by the 51(k)s that the report may be relevant to these poly-tapes. Co believes that the pre-existing patient condition may have contributed to the problem. Owing to the circumstances of the operations (foreign country, time since operations) it has not been possible to obtain all the information required concerning the operations performed and the patient details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8044102-2006-00001 |
| MDR Report Key | 680049 |
| Report Source | 01,05 |
| Date Received | 2006-02-24 |
| Date of Report | 2006-02-20 |
| Date Mfgr Received | 2006-01-31 |
| Date Added to Maude | 2006-03-02 |
| 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 | JIM ROWLAND |
| Manufacturer Street | SPRINGFIELD HOUSE WHITEHOUSE LANE |
| Manufacturer City | YEADON LS197UE |
| Manufacturer Country | UK |
| Manufacturer Postal | LS19 7UE |
| Manufacturer Phone | 132387200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLY-TAPE OR LEEDS-KEIO CTP |
| Generic Name | IMPLANTABLE ORTHOPAEDIC TAPE |
| Product Code | HXT |
| Date Received | 2006-02-24 |
| Model Number | 50X500MM |
| Catalog Number | 102-1015 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 669317 |
| Manufacturer | XIROS PLC |
| Manufacturer Address | SPRINGFIELD HOUSE WHITEHOUSE LANE YEADON, LEEDS UK LS19 7UE |
| Baseline Brand Name | POLY-TAPE OR LEEDS-KEIO CTP |
| Baseline Generic Name | IMPLANTABLE ORTHOPAEDIC TAPE |
| Baseline Model No | 50X500MM |
| Baseline Catalog No | 102-1015 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2006-02-24 |