MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 3-D HALO CROWN SYSTEM; COMPONENT, TRACTION, INVASIVE

Catalog Number 292301001

Device Problem Malposition of Device (2616)

Patient Problems Internal Organ Perforation (1987); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

Initially the reported product ¿3-dhalocrownset (292301001)¿ was mounted on the patient at another hospital (surgery date unknown).The patient moved to the second hospital (ogihara orthopedic hp), where the weekly skull-pin adjustment had been performed.It was reported that one skull pin had been excessively screwed in.Ct images showed the skull pin had completely been positioned inside the skull.The patient has suffered from functional disorder and been hospitalized.Although details of treatment at the second hospital are unknown, the patient is under recovery process.

• Brand Name: 3-D HALO CROWN SYSTEM
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6640427
• MDR Text Key: 77546781
• Report Number: 1526439-2017-10441
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K915800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 292301001
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention