MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLAS CABLE SYSTEM; WIRE, SURGICAL

Catalog Number 826-213

Device Problem Break (1069)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) (revision surgery).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient underwent surgery on (b)(6) 2015.On (b)(6) 2016, post-op, the patient felt unwell.X-ray image showed that stationary chuck and cable was out.The product came in the contact with the patient.Revision surgery will be performed.

Manufacturer Narrative

Image review: post op x-rays from c4-5 acdf with posterior sp wiring at c3-4, c4-5 shows wire fracture at c3.This head was not fused anteriorly.Fusion has also not occurred at the c3-4 facet.Root cause: surgical technique.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLAS CABLE SYSTEM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5750448
• MDR Text Key: 48190554
• Report Number: 1030489-2016-01899
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K892651
• 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,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Catalogue Number: 826-213
• Device Lot Number: 0332116W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR