MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48955116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a surgeon was performing a single level t-lift, l2-l3.Discectomy was completed with no issue.The surgeon prepared end plates and used proper inserter to insert interbody by lightly tapping with mallet inserter to put it in proper position.Surgeon checked fluoro and observed interbody appeared to turn obliquely 60 degrees.Surgeon removed the inserter with interbody and the top 1/3 attached to the inserter, while the remaining 2/3 shattered in pieces in the patient's body.All pieces were removed and surgeon took additional fluoro to confirm all particles where removed.Surgeon completed surgery with a new device and completed the surgery successfully.There was a reported surgical delay of 1 hour 15 minutes.There were no adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the reported event was confirmed via email correspondence with the sales rep and visual inspection of the returned broken piece.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.Materials analysis was performed on the returned broken piece.Mar concludes the cage fractured in ductile overload.No materials defects or manufacturing defects was observed.Conclusion: mar concludes the cage fractured in ductile overload however, the exact root cause of the reported event cannot be determined due to lack of information.Some potential factors that might be leading to the intra-op fractures.Thickness of wall adjacent to lateral window.Size of lateral window.User overestimating strength of implant and applying excessive force (torsional, cantilever).Not following surgical technique guide; using oversized implant or wrong type/size of inserter, not distracting when inserting or repositioning, use of ¿twist & distract¿ method.
Event or Problem Description
It was reported that a surgeon was performing a single level t-lift, l2-l3.Discectomy was completed with no issue.The surgeon prepared end plates and used proper inserter to insert interbody by lightly tapping with mallet inserter to put it in proper position.Surgeon checked fluoro and observed interbody appeared to turn obliquely 60 degrees.Surgeon removed the inserter with interbody and the top 1/3 attached to the inserter, while the remaining 2/3 shattered in pieces in the patient's body.All pieces were removed and surgeon took additional fluoro to confirm all particles were removed.Surgeon completed surgery with a new device and completed the surgery successfully.There was a reported surgical delay of 1 hour 15 minutes.There were no adverse health consequences to the patient.

• Brand Name: 11MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7331387
• Report Number: 3004024955-2018-00012
• Device Sequence Number: 11340823
• Product Code: MAX
• UDI-Device Identifier: 07613327118094
• UDI-Public: (01)07613327118094
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• 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): 09/25/2018

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 Model Number: 48955116
• Device Catalogue Number: 48955116
• Device Lot Number: D67Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR