MAUDE Adverse Event Report: DEPUY SYNTHES SPINE UNKNOWN HALO FIXATION PIN; COMPONENT, TRACTION, INVASIVE

Catalog Number UNK ¿ SPINAL IMPLANT

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 06/23/2016

Event Type  Injury  

Manufacturer Narrative

Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During application of a halo fixation system, the halo crown is fixed with 4 pins to the skull.One of these pins got wedged into the crown up to the point where not adequate fixation could be archived.As to how this event was solved is not exactly known yet.I can speak to the treating hcp next week.There was additional anesthesia needed for the skin of the patient and the procedure was lengthened.How much the procedure was lengthened is known at this time.The product as available for examination.This event is not uncommon to this user.Update 06 july 2016 - it seems that the threads in the ring are not correctly cut, as the pin jammed immediately in the ring.

• Brand Name: UNKNOWN HALO FIXATION PIN
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 5802326
• MDR Text Key: 49812950
• Report Number: 1526439-2016-10498
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2016

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?: No
• Device Operator: Physician
• Device Catalogue Number: UNK ¿ SPINAL IMPLANT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other