MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-03 for AWL (STAINLESS STEEL) 73711 manufactured by Alphatec Spine, Inc..
[107226470]
No evaluation possible at this time. The instrument has not been returned for evaluation. The illico awl is a cannulated instrument ground at 15? To form a sharp trocar tip intended to penetrate cortical bone during pedicle preparation. The section retained by the patient is manufactured from custom (b)(4) stainless steel which is processed and certified to astm (b)(4) specifications.
Patient Sequence No: 1, Text Type: N, H10
[107226491]
The distal tip of an illico awl broke off during the mis case. The detached section remains captured within the patients l5 pedicle.
Patient Sequence No: 1, Text Type: D, B5
[117897330]
An evaluation of the returned device confirmed the distal tip, approximately. 591 in length has been completely separated/detached from the instrument. Under magnification, the fracture patterns reveal lateral forces where applied to the instrument which caused the?. 20" tip to encounter excessive fatigue/stress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027467-2018-00023 |
| MDR Report Key | 7482962 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-04 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2008-07-11 |
| Date Added to Maude | 2018-05-03 |
| 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 | MR. RICHARD YOUNGER |
| Manufacturer Street | 5818 EL CAMINO REAL |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604946842 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AWL (STAINLESS STEEL) |
| Generic Name | HWJ |
| Product Code | HWJ |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-05-07 |
| Model Number | 73711 |
| Catalog Number | 73711 |
| Lot Number | 5148702 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPHATEC SPINE, INC. |
| Manufacturer Address | 5818 EL CAMINO REAL CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-03 |