MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for STRATAFIX SXPD2B400 manufactured by Surgical Specialties Corporation.
[128390624]
To date the complaint device has not been returned to surgical specialties for root cause analysis. A review of the device history records by manufacturing for the reported finished good lots, did not identify any quality issues during the incoming, manufacturing, in-process or final inspection processes.
Patient Sequence No: 1, Text Type: N, H10
[128390625]
Capsule rupture, in some cases wound dehiscence and leakage. Stratafix breaking during procedure, almost in the middle: infra pathelair/pathelair: 3 times. (knee surgery).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2018-00027 |
| MDR Report Key | 8102613 |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-11-01 |
| Date Facility Aware | 2018-11-01 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2017-12-23 |
| Date Added to Maude | 2018-11-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RONALD GIANNANGELO |
| Manufacturer Street | 247 STATION DRIVE SUITE NE1 |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| Manufacturer G1 | SURGICAL SPECIALITIES CORPORATION |
| Manufacturer Street | CORREDOR TIJUANA-ROSARITO 2000 #24702B EJIDO FRANCISCO VILLA |
| Manufacturer City | TIJUANA 22235 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRATAFIX |
| Generic Name | STRATAFIX 2MO-4 #2 PDO 36 X 36 |
| Product Code | GAB |
| Date Received | 2018-11-26 |
| Model Number | SXPD2B400 |
| Catalog Number | SXPD2B400 |
| Lot Number | AACE037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORPORATION |
| Manufacturer Address | CORREDOR TIJUANA ROSARITO 2000 24702-B EJIDO FRANCISCO VILLA TIJUANA 22235 MX 22235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-26 |