MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-17 for SPOT 2MM, 45 UP ANGLE MICROPI 292904202 manufactured by Depuy Spine Inc.
[148201258]
Product complaint # (b)(4). (b)(6). Udi: (b)(4), unknown. A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[148201259]
It was reported on (b)(4) 2019 during microdiscectomy, the spotlight access system up angle micropituitary was broken, surgeon removed the broken piece with difficulty. Procedure outcome and patient consequence are unknown. This complaint involves one (1) device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51766 |
| MDR Report Key | 8704927 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-17 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-05-23 |
| Date Mfgr Received | 2019-08-16 |
| Device Manufacturer Date | 2016-05-19 |
| Date Added to Maude | 2019-06-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SPINE INC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPOT 2MM, 45 UP ANGLE MICROPI |
| Generic Name | RONGEUR |
| Product Code | HTX |
| Date Received | 2019-06-17 |
| Returned To Mfg | 2019-07-30 |
| Model Number | 292904202 |
| Catalog Number | 292904202 |
| Lot Number | KW16400411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-17 |