MAUDE Adverse Event Report: STRYKER SPINE-US 10X27X10X6 DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48930106
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device was discarded.
Event or Problem Description
It was reported that during cage insertion a tritanium curved posterior lumbar cage became jammed and remained stuck to a tritanium steerable inserter and a tritanium steerable inserter shaft.The procedure was completed successfully using a replacement cage with a 25 minute surgical delay and no adverse consequence to the patient.This report captures the tritanium curved posterior lumbar cage.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
It was reported that during cage insertion a tritanium curved posterior lumbar cage became jammed and remained stuck to a tritanium steerable inserter and a tritanium steerable inserter shaft.The procedure was completed successfully using a replacement cage with a 25 minute surgical delay and no adverse consequence to the patient.This report captures the tritanium curved posterior lumbar cage.

• Brand Name: 10X27X10X6 DEG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18311276
• Report Number: 0009617544-2023-00085
• Device Sequence Number: 6278129
• Product Code: MAX
• UDI-Device Identifier: 07613327369281
• UDI-Public: 07613327369281
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 48930106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown