MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-06-07 for CROWN SET SM HT035 manufactured by Depuy Synthes Spine.
[46713073]
(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
[46713074]
Upon application of a halo crown on a trauma patient, 4 skull pins are fixed to the patients skull. The skull pins used were supplied with the halo crown. Three (3) pins were inserted without a problem, the 4th jammed in the ring before it could be tightened to the skull. A new pin was used and gave the same problem; the hcp decided to use this 5th pin again in a hole adjacent to the problem hole and the skull pin could be inserted without a problem. As all 4 insertion sites had already been anesthetized, the alternative insertion site needed an additional injection. This caused delay to the procedure and an additional usage of anesthetization fluid in the patient. The hcp had to report this internally in the hospital quality system as a patient care incident report. A second skull pin was used, to no effect, eventually this pin was inserted in another hole in the halo crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2016-10398 |
| MDR Report Key | 5703615 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-06-07 |
| Date of Report | 2016-05-11 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-06-07 |
| 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 | MICHAEL JACENE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776485 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROWN SET SM |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2016-06-07 |
| Catalog Number | HT035 |
| Lot Number | 062008 |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2016-06-07 |