MAUDE Adverse Event Report:

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The alleged screw failure cannot be confirmed.Dhr review and product investigation cannot be completed as no part or lot number have not been identified.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.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 july 15th, 2019, seaspine was made aware of a complaint that alleges a screw failure.On july 30th, 2019, seaspine received a medical product claim letter describing the possible index surgery.The surgery consisted of was a lumbar laminectomy l4 and l5, plus instrumentation l4 l5 - with l4 l5 s1, spondylolisthesis l4-l5 and l5-s1.No x-rays or radiographs have been provided.Multiple attempts have been made to retrieve any additional information.

• Brand Name: NA
• Type of Device: NA
• Manufacturer Contact: aaron ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 8893597
• MDR Text Key: 199252531
• Report Number: 3012120772-2019-00023
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR