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 2013-10-02 for 3-D HALO CROWN SYSTEM 292301001 manufactured by Depuy Synthes Spine.
[3753090]
International affiliate reports that during surgery, a screw could not be assembled at the front slider of the 3d halo crown because the hole for the screw was deformed. Affiliate reports that because time was running out, the customer used a sterilized slider from another 3d halo crown that had been previously used to complete the procedure. The surgery was delayed by two hours while the patient was under anesthesia. The patient was maintained in a stable position while awaiting sterilization of the of the second slider and did not suffer any adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[11116333]
A follow up report will be filed upon completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19064470]
The product sample is not available for evaluation as it was discarded by the customer. Without the device the lot number is unknown, therefore, without a lot number; a review of the device history record (dhr) cannot be conducted. A review of the complaint trend analysis found no observed trends for issues of this nature. Therefore, without a product sample and no identified trend we are unable to confirm the reported issue or identify the root cause. In the absence of a product sample, lot number, or observed trend, this complaint will be closed with no further action required. If the complaint product sample becomes available, the complaint file will be re-opened and the product evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2013-29175 |
| MDR Report Key | 3381811 |
| Report Source | 01,05,07 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-09-15 |
| Date of Event | 2013-09-15 |
| Date Mfgr Received | 2013-09-15 |
| Date Added to Maude | 2013-10-02 |
| 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 | 3-D HALO CROWN SYSTEM |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2013-10-02 |
| Catalog Number | 292301001 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-10-02 |