MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-08-21 for CLASSIC II VEST LGE-INTERNATIONAL CV102W manufactured by Depuy Synthes Spine.
[3833536]
International affiliate reports that a posterior locking knob on the classic ii halo vest procedure set was broken while the patient was lying in bed, resulting in instability of the halo system. A knob taken from another vest at the hospital was used in its place. The patient did not experience any adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[11065354]
A follow up report will be filed upon receipt of the device and completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[27390291]
Visual inspection of the returned knob for the classic ii vest noted that the threaded feature was fractured. No other visual anomalies were noted during the device evaluation. Review of the device history record found no discrepancies. The product was released accomplishing all quality requirements. Review of product complaints found no emerging trends. The root cause of the knob failure is unknown. However, the knob may have been subjected to an unanticipated level of stress resulting in fracture. No corrective action is required as there has been no issue identified in the manufacturing or release of the device and there has been no observed systemic trend. Therefore, the complaint will be closed with no further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2013-24627 |
| MDR Report Key | 3299968 |
| Report Source | 01,05,07 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-08-08 |
| Date of Event | 2013-07-16 |
| Date Mfgr Received | 2013-08-08 |
| Device Manufacturer Date | 2013-01-18 |
| Date Added to Maude | 2013-11-18 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | BETH BECOTTE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283575 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| 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 | CLASSIC II VEST LGE-INTERNATIONAL |
| Generic Name | ORTHOSIS, CERVICAL-THORACIC, RIGID |
| Product Code | IQF |
| Date Received | 2013-08-21 |
| Returned To Mfg | 2013-08-27 |
| Catalog Number | CV102W |
| Lot Number | 057954 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-21 |