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 2019-06-17 for XPDM THORACIC PEDICLE PRB, CRV 279702040 manufactured by Depuy Spine Inc.
[148265049]
(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
[148265050]
It was reported that on (b)(6) 2019, during a posterior spinal fusion on a patient with hard bone, while creating a pathway for the screw into the pedicle, the thoracic probe broke at the distal end tip. This piece was retrieved and nothing was left inside the patient. Also, when doing final tightening, the torque driver shaft stripped at the distal end tip. There were fragments generated but was easily removed. The procedure was completed successfully. The patient did not suffer due to these brakes. Concomitant device reported: unknown polyaxial screw (part # unknown, lot # unknown, quantity# unknown). This complaint involves two (2) devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51769 |
| MDR Report Key | 8705160 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-17 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-05-28 |
| Date Mfgr Received | 2019-08-14 |
| Device Manufacturer Date | 2013-06-20 |
| Date Added to Maude | 2019-06-17 |
| 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 | 2019-06-17 |
| Returned To Mfg | 2019-06-18 |
| Model Number | 279702040 |
| Catalog Number | 279702040 |
| Lot Number | NW136373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-06-17 |