MAUDE Adverse Event Report: DEPUY SYNTHES SPINE UNKNOWN ROD

Catalog Number UNK ¿ SPINAL IMPLANT

Device Problem Break (1069)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 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

Maude report received from fda: mw5064317.Reporter called on behalf of daughter who had an implant for the first time on (b)(6) 2013 for sclerosis.Two rods were implanted and pt was hospitalised for 9 days.Shortly after she got home, she started screaming in pain.When the doctor was called, he told patient to go to sleep and never to call him again at 2am.Three days later, it was discovered that the rods were broken.The doctor took off the broken rods and replaced with two other rods and additional screws were put in.Surgery took close to 10 hours and after the surgery, she had face swelling and the anesthesia altered her thinking.She was later taken for a 2 week check up and doctor said she should find another doctor.The only doctor she found did another surgery and implanted 4 rods and fused her back.She came out of surgery with swollen chin, blisters inside her mouth and on her tongue.She couldn't eat or drink.Even till date, if she smells any chemical it burns her throat.The third set of rods are broken again and no doctor will see her.She read on the internet that some representatives were selling defective rods.At the moment, patient's feet are swollen, she has pressure in her back and chest, blood clot in her lungs and a lot of back pain.The doctors now say they have to break her back because her back was fused by the previous doctor.

• Brand Name: UNKNOWN ROD
• Type of Device: UNKNOWN
• 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: 6038008
• MDR Text Key: 57780882
• Report Number: 1526439-2016-10783
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/22/2016,09/23/2016

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?: Yes
• Device Operator: Physician
• Device Catalogue Number: UNK ¿ SPINAL IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2016
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention