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

Catalog Number	33661405MR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by surgical staff.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8562273
• Report Number: 0009617544-2019-00059
• Device Sequence Number: 11311065
• Product Code: MQP
• UDI-Device Identifier: 04546540389275
• UDI-Public: 04546540389275
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 33661405MR
• Device Lot Number: 173576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 85