MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48955096
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A tritanium pl cage fractured intra-operatively during cage insertion leading to a 5 minute surgical delay.
Event or Problem Description
A tritanium pl cage fractured intra-operatively during cage insertion leading to a 5 minute surgical delay.
Additional Manufacturer Narrative
The visual inspection revealed that the cage was returned in 2 pieces, fractured in half, with the left side top post pushed upward.The other 3 posts were not returned.The device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.From the tritanium pl surgical technique: 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.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 the disc space was not distracted, there was no twisting or rotation applied during insertion, no trials were used, the avs pl 11mm inserter was used, the implant was not at a difficult angle, no cantilever force was used, implant was not repositioned, es2 was installed as the supplemental fixation, and no compression was applied.It was reported that the user did not distract and trialing was not performed.These are both root causes identified for tritanium pl fractures and these steps are outlined in the tritanium pl surgical technique.

• Brand Name: 9MM X 6DEG X11MM 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: 9229757
• Report Number: 3004024955-2019-00043
• Device Sequence Number: 19372745
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: 07613327118070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 02/21/2022
• Device Catalogue Number: 48955096
• Device Lot Number: D016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1