MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-27 for XTENDOBUTTON FIXATION DEVICE 72200134 manufactured by Smith & Nephew, Inc..
[24357648]
The product is an implant device and was therefore not returned for the investigation. The product has not been removed from the patient at this time. The device is undergoing an evaluation but has not yet been completed. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[24357649]
It was reported that the patient received an anterior cruciate ligament procedure on (b)(6) 2013. Sometime post-operative the patient developed an infection. There have been no products removed from the patient at this time. It was reported that nothing unusual occurred on the date of surgery. The patient was reported as fine. The patient had surgical washout and was given antibiotic beads and oral antibiotics. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2015-00927 |
| MDR Report Key | 5036153 |
| Date Received | 2015-08-27 |
| Date of Report | 2013-02-28 |
| Date of Event | 2013-01-16 |
| Date Mfgr Received | 2013-03-27 |
| Device Manufacturer Date | 2012-06-22 |
| Date Added to Maude | 2015-08-27 |
| 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 | 3 |
| Manufacturer Contact | JAMES GONZALES |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 5123585706 |
| 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 | 0 |
| Brand Name | XTENDOBUTTON FIXATION DEVICE |
| Generic Name | RETENTION DEVICE, SUTURE |
| Product Code | KGS |
| Date Received | 2015-08-27 |
| Catalog Number | 72200134 |
| Lot Number | 50424632 |
| ID Number | 200 |
| Device Expiration Date | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-08-27 |