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 2018-06-28 for SKY SELF CENTERING AWL 286820400 manufactured by Depuy Spine Inc.
[112858230]
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation 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
[112858231]
Self centering awl tip broke when pressure was applied to the anterior aspect of vetebral body. Patient consequence? :no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50612 |
| MDR Report Key | 7646560 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-28 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2006-05-31 |
| Date Added to Maude | 2018-06-28 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| 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 | SKY SELF CENTERING AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2018-06-28 |
| Model Number | 286820400 |
| Catalog Number | 286820400 |
| Lot Number | 0406V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-06-28 |