MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2018-12-20 for STRATAFIX SXPD2B412 manufactured by Surgical Specialities.
[131020257]
To date, the complaint device has not been returned to surgical specialties corporation for root cause analysis. The lot number have not been provided which precludes a dhr review from being performed at this time including sterility records. Unfortunately without the lot information we are unable to determine a root cause at this time. Should the device be returned to surgical specialties corporation at some point in the future the issue will be re-opened, the device evaluated and the findings from the evaluation will be documented in the complaint file and a follow-up report will be filed at that time. Pdo (polydioxanone) 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
[131020258]
It was reported by the distributor/sales rep that a patient presented with skin irritations and suture spitting. An email was received by the distributor that a skin graft may be required to repair infected or damaged tissue however to date no additional information has been forth coming regarding whether surgical intervention was performed. Pdo (polydioxanone) 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: D, B5
| Report Number | 3010692967-2018-00031 |
| MDR Report Key | 8184587 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 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 | 2005-01-14 |
| Date Added to Maude | 2018-12-20 |
| 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 |
| Manufacturer G1 | SURGICAL SPECIALITIES |
| Manufacturer Street | RD 495 MONTANA INDUSTRIAL PK |
| Manufacturer City | AQUADILLA PR 00605 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATAFIX |
| Generic Name | STRATAFIX PDO |
| Product Code | GAB |
| Date Received | 2018-12-20 |
| Model Number | SXPD2B412 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALITIES |
| Manufacturer Address | RD 459 MONTANA INDUSTRIAL PARK AQUADILLA PR 00605 US 00605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |