MAUDE Adverse Event Report: STRYKER SPINE-US VBOSS 14MM LARGE ROUND ENDCAP 5 DEG; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 33661405MR

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

Device discarded by surgical staff.

Event Description

Physician reported that following, "a few hammer blows on the implant holder to impact the cage," the upper end cap of the vboss system broke at the base and disengaged from the cage.The physician removed and straightened the cage (which had "twisted") and replaced the upper end cap.There was a two-hour delay in the surgery.All broken fragments were removed, surgery was successfully completed, and no other adverse consequence was reported.

Event Description

Physician reported that following, "a few hammer blows on the implant holder to impact the cage," the upper end cap of the vboss system broke at the base and disengaged from the cage.The physician removed and straightened the cage (which had "twisted") and replaced the upper end cap.There was a two-hour delay in the surgery.All broken fragments were removed, surgery was successfully completed, and no other adverse consequence was reported.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.From vboss surgical technique: if increased surface area is desired, oval endcaps should be used.The oval endcaps maximize the implant footprint on the vertebral end plate for greater load bearing, load sharing and stability.Two cage inserters are provided.The standard cage inserter is intended for cages greater than 25mm in height.It provides a tight grasp of the cage through two of the cage perforations.Using the same locking function, the small cage inserter is intended for smaller cages.If the cage needs to be adjusted once in position, use the cage impactor.The impactor has a pin at the tip which is intended to engage the perforations of the cage and to prevent unintentional slippage.It was reported that the endcap of vboss cage fractured while impacting the cage to seat properly in patient's anatomy.Since the implant was not returned, an exact root cause of reported event could not be determined conclusively but most likely due to excessive impaction force applied to seat the implant.

• Brand Name: VBOSS 14MM LARGE ROUND ENDCAP 5 DEG
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8562273
• MDR Text Key: 143592880
• Report Number: 0009617544-2019-00059
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 04546540389275
• UDI-Public: 04546540389275
• Combination Product (y/n): N
• PMA/PMN Number: K033837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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: Health Professional
• Device Catalogue Number: 33661405MR
• Device Lot Number: 173576
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 85