MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,07 report with the FDA on 2000-03-16 for ACUFEX, SURETAC II W/SPIKES, STERILE 014567 manufactured by Smith & Nephew, Inc., Endoscopy Division.
[18604535]
Mfr became aware of an operative written, in which four cases of post-op complications followed the use of co's suretac implant. Co is filing this mdr based on the info that was available in the article and through company reresentative in a foreign resulted from the lack of postoperative immobilization and the stress placed on the joints from aggressive rehabilitation programs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2000-00015 |
| MDR Report Key | 270115 |
| Report Source | 01,03,07 |
| Date Received | 2000-03-16 |
| Date Mfgr Received | 2000-02-17 |
| Date Added to Maude | 2000-03-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TEDD GOSIAN |
| Manufacturer Street | 130 FORBES BLVD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082613771 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFEX, SURETAC II W/SPIKES, STERILE |
| Generic Name | BIOABSORBABLE FIXATION DEVICE |
| Product Code | MBJ |
| Date Received | 2000-03-16 |
| Model Number | NA |
| Catalog Number | 014567 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 261506 |
| Manufacturer | SMITH & NEPHEW, INC., ENDOSCOPY DIVISION |
| Manufacturer Address | 160 DASCOMB RD ANDOVER MA 01810 US |
| Baseline Brand Name | ACUFEX, SURETAC II W/SPIKES STERILE |
| Baseline Generic Name | BIOABSORBABLE FIXATION DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | 014567 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-03-16 |