MAUDE Adverse Event Report: STRYKER SPINE-US AERO-LL LUMBAR CAGE SYSTEM 8X50MMX0DEG - 18; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number	48940208
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a blade for a cage broke when the surgeon tried to mallet it into the vertebral body.The issue was noticed on x-rays.Unknown if broken fragments will be retried.No patient harm and no surgical delay was reported at this time.
Additional Manufacturer Narrative
Correction: fda registration # to (b)(4).Section g1 manufacturing site updated to stryker spine-france method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the sales rep reported event was confirmed via visual inspection of returned device.The event resulted in a 20 minutes surgical delay and no adverse consequences to the patient.All broken fragments were retrieved.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Upon complaint history review and nc/capa history review, no relevant complaints/ nc/capa were identified.It was reported that anchor stopped advancing during insertion.After malleting a bit harder, an x-ray was taken showing the anchor had broken.Conclusion: the most likely cause of the reported event was determined to be user error- application of excessive insertion force by malleting the anchor.
Event or Problem Description
It was reported that a blade for a cage broke when the surgeon tried to mallet it into the vertebral body.The issue was noticed on x-rays.Unknown if broken fragments will be retried.No patient harm and no surgical delay was reported at this time.

• Brand Name: AERO-LL LUMBAR CAGE SYSTEM 8X50MMX0DEG - 18
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8061074
• Report Number: 0002530131-2018-00002
• Device Sequence Number: 1929020
• Product Code: OVD
• UDI-Device Identifier: 07613327065725
• UDI-Public: 07613327065725
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: No Information
• Device Catalogue Number: 48940208
• Device Lot Number: 14G484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1