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 2018-06-26 for UNKNOWN BREMER DEVICES UNK BREMER DEVICES manufactured by Depuy Spine Inc.
[112310513]
(b)(4). 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
[112310514]
This report is being filed after the subsequent review of the following literature article: one-stage posterior resection is feasible for a holovertebral aneurysmal bone cyst of the axis: a case report and literature review. Li-yu fay, mda,c,d, jau-ching wu, mda,b,c,e, wen-cheng huang, mda,b,c, yang-hsin shih, mda,c,d, henrich cheng, md, phda,b,c,e. N=1: infection at skull pin site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2018-50588 |
| MDR Report Key | 7637596 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-01 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-06-26 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | UNKNOWN BREMER DEVICES |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2018-06-26 |
| Catalog Number | UNK BREMER DEVICES |
| 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 | 1. Required No Informationntervention | 2018-06-26 |