MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) manufactured by Integra Lifesciences Corporation.
[177799961]
During removal of the mayfield radiolucent skull pins, neurosurgical fellow noted retained particles left in left sided pin site. Fellow removed retained particles, pins placed into biohazard bag, manufacturer information recovered. No harm to patient. Manufacturer response for mayfield radiolucent skull pin, (brand not provided) (per site reporter). Unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670518 |
| MDR Report Key | 9670518 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-10 |
| Report Date | 2020-01-30 |
| Date Reported to FDA | 2020-01-30 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) |
| Product Code | HBL |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-01-10 |
| Lot Number | W1808188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 1100 CAMPUS RD PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |