MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-06-23 for CURETTE, SPINAL (COBB) 23-2571 manufactured by Codman & Shurtleff, Inc..
[15144690]
Affiliate reported that the spoon curette broke during the surgery into the vertebral area. So the surgeon had to spend time to find the product inside the patient. There was no injury to the nerves. It is not known how long the delay was in surgery.
Patient Sequence No: 1, Text Type: D, B5
[15455852]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2011-00226 |
| MDR Report Key | 2152168 |
| Report Source | 01,07 |
| Date Received | 2011-06-23 |
| Date of Event | 2011-05-23 |
| Date Mfgr Received | 2011-05-25 |
| Date Added to Maude | 2011-08-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN & SHURTLEFF, INC. |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURETTE, SPINAL (COBB) |
| Generic Name | INSTRUMENTS |
| Product Code | FZS |
| Date Received | 2011-06-23 |
| Model Number | NA |
| Catalog Number | 23-2571 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-23 |