MAUDE Adverse Event Report: STRYKER SPINE-US 8MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48955086
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage fractured post op after lifting a heavy object.Reported that revision will be needed in the future.
Additional Manufacturer Narrative
Updated adverse event and product problem to product problem.Updated executive summary to include new information.Operator of device added.Date of implant added.Updated adverse event to malfunction.Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed upon x-ray image review.The supplemental fixation system looks fine on x-ray image review.The device has not been received back as it's still implanted in the patient, therefore, product evaluation couldn't be performed.Manufacturing record was reviewed, and no relevant issues were identified.It's reported that the patient was instructed, not to lift heavy things and not to jump (gym) for the next 2 month.It¿s also reported that a scrub nurse impacted the bone graft with impactor using a huge hammer.Impactor and cage were not in line while a nurse was using the hammer." per surgical technique, only graft compactor is supposed to be used for bone graft placement.The hammer is not included in the surgical technique.Therefore, it¿s likely that a potential crack has been initiated when the bone graft was impacted inside the cage via off-axial overload by the reported hammer.Conclusion: the plausible root cause of the reported event is the deviation from surgical technique - off-axial overload while impacting the bone graft into the reported cage using a hammer which is not included in the surgical technique.Stryker has decided to take a field action (3004024955-11/14/18-001-c).Specifically, stryker executed a correction by updating the surgical technique guide to warn end users against misuses which include extreme surgical techniques that fall outside the approved instructions for use.Device still remains implanted in the patient.
Event or Problem Description
It was reported that the cage fractured post op after lifting a heavy object.Reported that revision will be needed in the future.Based on the new information received on december 4, 2018, it was confirmed that no revision surgery required.The patient is stable, pain free and fusion has started.No need to wear corsage.No other consequence to the patient was reported.

• Brand Name: 8MM 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: 8011504
• Report Number: 3004024955-2018-00052
• Device Sequence Number: 19177442
• Product Code: MAX
• UDI-Device Identifier: 07613327118063
• UDI-Public: 07613327118063
• Combination Product (Y/N): N
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48955086
• Device Lot Number: AAEN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR