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 2019-12-05 for UNKNOWN AWLS UNK AWLS manufactured by Depuy Spine Inc.
[185304759]
Product complaint #: (b)(4). 510k: this report is for an unknown awe/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. 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
[185304760]
Device report from synthes reports an event in (b)(6) as follows: it was reported that dr (b)(6) was performing a l4-5 right sided navigated posterior instrumented fusion on the patient at (b)(6) hospital. When using the modified pedicle awl with sleeve, the tip was damaged. The nurse informed the dr. That she was unsure if the tip had come off in the patient as she did could not find it. The dr. Was not concerned with this and on the x-ray taken at the completion of the procedure, no tip or fragment was seen. No delay was experienced. The awl has been tagged for repair and is currently at the hospital. The surgeon completed the procedure, the damaged awl was not used again. Patient status/ outcome / consequences are unknown. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-52587 |
| MDR Report Key | 9417535 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-05 |
| Date of Report | 2019-11-12 |
| Date Mfgr Received | 2019-11-12 |
| Date Added to Maude | 2019-12-05 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN AWLS |
| Generic Name | EXPEDIUM? VERSE SPINE SYSTEM |
| Product Code | HWJ |
| Date Received | 2019-12-05 |
| Catalog Number | UNK AWLS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-12-05 |