MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device are currently unknown.
Event or Problem Description
It was reported that a tritanium pl cage fractured during intra-operative placement at the l4/5 leading to a 10 minute surgical delay.The physician reported that some fragments could not be retrieved and remained in the surgical site.The surgery was successfully completed by implanting a new cage in a more posterior position.
Event or Problem Description
It was reported that a tritanium pl cage fractured during intra-operative placement at the l4/5 leading to a 10 minute surgical delay.The physician reported that some fragments could not be retrieved and remained in the surgical site.The surgery was successfully completed by implanting a new cage in a more posterior position.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From the tritanium pl surgical technique: choose a cage that is equivalent to the final trial height or final distractor used.The implant sizing is based on the fit and feel of either the final trial or distractor.Implant height should not be oversized.Carefully insert the cage with the inserter in-line with the disc space and in the orientation that the cage is intended to sit as shown in figure 19.When necessary, a mallet can be used to gently progress the cage.Avoid using the insertion techniques shown in figures 20-22.The same methods and orientation above are to be used for intra-operative removal of the cage, when deemed medically necessary as described on page 20.Optimal positioning may be facilitated by directing the implant obliquely until it contacts the ventral annulus (figure 19).If difficulty is encountered while inserting the implant, it most likely represents: contralateral disc material which may be blocking passage of the implant, inadequate distraction, an undersized annulotomy, or oversized implant check for adequacy of the discectomy; ensure that distraction is maintained, and remove the impediment.Then, continue to insert the implant.The distraction should be released to facilitate optimal placement of the implant.Precaution: do not twist, cantilever or rotate to achieve final position.This may result in damage to the implant.It was reported that trialing was not performed and cantilever force was applied to insert the implant into tight disc space that the surgeon was having difficulty inserting the implant into.Lack of trialing and user overestimating strength of implant and applying excessive force (torsional, cantilever) were both identified in a previous capa as root causes identified for tritanium pl fractures.Trialing is a step outlined in the tritanium pl stg.The stg also warns against cantilevering the implant during insertion.

• Brand Name: 10MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9454606
• Report Number: 3004024955-2019-00051
• Device Sequence Number: 19602566
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: 07613327118087
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• 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
• Report Date (Section B): 02/27/2020

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 Expiration Date: 02/18/2023
• Device Model Number: 48955106
• Device Catalogue Number: 48955106
• Device Lot Number: E763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR