MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-03 for TWINFIX TI 3.5 ULTRABRAID 72200752 manufactured by Smith & Nephew, Inc..
[177608887]
It was reported that, 20 days after an open reduction and fixation procedure with a twinfix, swelling, redness and secretion overflow were found over the incision site. On 1/16/20 the implant was removed from within the patient. The fracture line is no longer visible. The patient's outcome is unknown. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2020-00163 |
| MDR Report Key | 9662563 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-03 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-10-11 |
| Date Added to Maude | 2020-02-03 |
| 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 | 3 |
| Manufacturer Contact | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TWINFIX TI 3.5 ULTRABRAID |
| Generic Name | STAPLE, FIXATION, BONE |
| Product Code | JDR |
| Date Received | 2020-02-03 |
| Model Number | 72200752 |
| Catalog Number | 72200752 |
| Lot Number | 50763854 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-03 |