MAUDE Adverse Event Report:; N/A

Device Problem Crack (1135)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/08/2013

Event Type  malfunction  

Manufacturer Narrative

On january 8th, 2019, seaspine was made aware of a complaint filed to (b)(6).The complaint alleges a cracked cervical plate at levels c5-c7.Dhr review and product investigation cannot be completed as no part or lot number have not been identified.No patient information is available.No x-rays or radiographs have been provided.Review of labeling notes: possible adverse events: bending, disassembly or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.Postoperative warnings: the patient should be advised that implants may bend, break or loosen despite restriction in activity.The root cause is unknown, as additional information is unavailable.No conclusions can be drawn at this time.

Event Description

On january 8th, 2019, seaspine was made aware of a complaint filed to (b)(6).The complaint alleges a cracked cervical plate at levels c5-c7.On (b)(6) 2013, the plaintiff had a c5-c7 anterior cervical discectomy fusion with instrumentation performed.On (b)(6) 2016, supposed x-ray performed showed a cracked cervical plate.It is unknown if revision surgery has occurred.It is unknown the current patient condition.

• Type of Device: N/A
• Manufacturer Contact: aaron ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 8313399
• MDR Text Key: 136135182
• Report Number: 3012120772-2019-00002
• 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: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1