MAUDE Adverse Event Report: STRYKER SPINE-US 7MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48954076
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that a tritanium pl cage fractured intra-operatively.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.The lot number provided by the field representative does not align with the catalog provided, therefore, device and complaint history records could not be reviewed as a valid lot code was not provided and could not be obtained.Sgt was reviewed for potential causes: 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.Precaution: do not twist, cantilever or rotate to achieve final position.This may result in damage to the implant.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.Due to no product return and insufficient information received the root cause could not be determined conclusively.
Event or Problem Description
It was reported that a tritanium pl cage fractured intra-operatively.The procedure was completed successfully without surgical delay.

• Brand Name: 7MM X 6DEG X 9MM 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: 11848176
• Report Number: 3004024955-2021-00007
• Device Sequence Number: 14383648
• Product Code: MAX
• UDI-Device Identifier: 07613327117943
• UDI-Public: 07613327117943
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 48954076
• Device Catalogue Number: 48954076
• Device Lot Number: E8KE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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
• Patient Weight: 233