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 2019-08-15 for XPDM THORACIC PEDICLE PRB, CRV 279702040 manufactured by Depuy Spine Inc.
[179720048]
(b)(4). The 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
[179720050]
Broken 279702040. Was surgery delayed due to the reported event? No. Was procedure successfully completed? Yes. Were fragments generated? Yes. If yes, were they removed easily without additional intervention? Yes. Patient status/ outcome / consequences: no. Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? No. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: no. Is the patient part of a clinical study: unknown. This complaint involves one (1) device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51975 |
| MDR Report Key | 8896333 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-15 |
| Date of Report | 2019-07-29 |
| Date Mfgr Received | 2019-10-15 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2019-08-15 |
| 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 | XPDM THORACIC PEDICLE PRB, CRV |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-08-15 |
| Model Number | 279702040 |
| Catalog Number | 279702040 |
| Lot Number | 1210NT |
| 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 | 2019-08-15 |