MAUDE Adverse Event Report: STRYKER SPINE-US VBOSS SMALL CAGE INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	33660700
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of a vboss small cage inserter was loose and dislodged during cage insertion.Subsequently, it made contact with the spinal cord resulting in a decrease in mep values.Mep values recovered and surgery was successfully completed.
Event or Problem Description
It was reported that the tip of a vboss small cage inserter was loose and dislodged during cage insertion.Subsequently, it made contact with the spinal cord resulting in a decrease in mep values.Mep values recovered and surgery was successfully completed.
Additional Manufacturer Narrative
Device has been received (d.9) and lot number (d.4) has been populated.
Additional Manufacturer Narrative
'a visual inspection was performed.Wear was identified on the device tip with deformation on the threads that assist with connecting the inserter and the implant.The laser marking is fading off.A functional inspection was performed.The inserter was connected with a sample vboss cage and the connection was not stable most likely due to the deformation/wear on the tip and the threads.The device is no longer functional.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.The instrument was in use for about 7 years.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Initial report states that a vboss small cage inserter's grip was weak, and it is likely that the inserter was dislodged during cage insertion and contacted the spinal cord, resulting in a decrease in motor evoked potentials (mep) values.Mep values recovered and surgery was successfully completed.The general device ifu was reviewed: ¿the life of the instruments depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order¿.Visual inspection and age of the device indicates that the reported issue is likely due to normal wear and tear and extensive use of the instrument.
Event or Problem Description
It was reported that the tip of a vboss small cage inserter was loose and dislodged during cage insertion.Subsequently, it made contact with the spinal cord resulting in a decrease in mep values.Mep values recovered and surgery was successfully completed.

• Brand Name: VBOSS SMALL CAGE INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13499334
• Report Number: 0009617544-2022-00012
• Device Sequence Number: 4779491
• Product Code: LXH
• UDI-Device Identifier: 07613327262681
• UDI-Public: 07613327262681
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 33660700
• Device Catalogue Number: 33660700
• Device Lot Number: 14F019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/17/2022; 04/21/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/16/2022; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown