MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-12-04 for STRATAFIX SXPD2B412 manufactured by Surgical Specialties Puerto Rico, Inc..
[129192647]
To date, the complaint device has not been returned to surgical specialties corporation for root cause analysis. The lot number has not been provided which precludes a dhr review from being performed at this time. Unfortunately without the device or lot information we are unable to determine a root cause at this time. Should the device be returned or additional information received about the events, surgical specialties corporation the file will be re-opened. Pdo (polidioxanone) material is essentially absorbed between 182 and 238 days post implantation. However, this specific material has in vivo strength retention for up to six (6) weeks. All sutures are technically? Foreign substances? That the human body has a tendency to reject. Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months. Still in some cases, the body decides not to break them down but instead pushes them out through the top of the skin. That is why it is not uncommon for spitting sutures to occur. Spitting of suture material can also be the result of placing the material too superficially. The suture size, type, depth, and technique utilized for each specific procedure can be an important factor in determining an exact root cause for this type of event. Without receiving detailed information regarding the procedure, technique and post-operative details, a definitive root cause cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[129192648]
It was reported to the sales rep that nine patients in the last month have experienced skin irritations and suture spitting. Today the customer emailed the sales rep to inform the sales rep of this and they were headed to the or and most likely will have to did a skin graft on this patient. The pa and doctor believe it has to due with the stratafix suture since they have not changed anything with technique or products in the last years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2018-00028 |
| MDR Report Key | 8128908 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-12 |
| Date Facility Aware | 2018-11-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2018-12-04 |
| 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 | MR. RONALD GIANNANGELO |
| Manufacturer Street | 247 STATION DRIVE SUITE NE1 |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATAFIX |
| Generic Name | STRATAFIX SPIRAL PDO |
| Product Code | GAB |
| Date Received | 2018-12-04 |
| Model Number | SXPD2B412 |
| Catalog Number | SXPD2B412 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES PUERTO RICO, INC. |
| Manufacturer Address | RD.459 MONTANA INDUSTRIAL PARK AQUADILA 00605 US 00605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-04 |