MAUDE Adverse Event Report: STRYKER SPINE-US AERO LL FIXATION ANCHOR, 50MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number	48940050
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor was damaged(bent upward) while inserting at l3 vertebrae.The surgeon removed the anchor and tried using second anchor which was deformed again.The surgeon decided not to place blade on the superior level.The surgeon was content with the amount of fixation and completed surgery successfully (facet fusion with micro decompression on the posterior side) using another anchor.It was also reported that the patient had concrete bone quality and the surgeon attributed much of event to the bone quality of the patient.A surgical delay of close to an hour was reported.No other adverse consequence to the patient was reported.
Event or Problem Description
It was reported that the anchor was damaged(bent upward) while inserting at l3 vertebrae.The surgeon removed the anchor and tried using second anchor which was deformed again.The surgeon decided not to place blade on the superior level.The surgeon was content with the amount of fixation and completed surgery successfully (facet fusion with micro decompression on the posterior side) using another anchor.It was also reported that the patient had concrete bone quality and the surgeon attributed much of event to the bone quality of the patient.A surgical delay of close to an hour was reported.No other adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Correction to g.5.(510k): updated from k142066 to k151726 visual inspection confirmed that tip of the anchor was deformed.Material analysis concluded the measured hardness of the cutter was found to meet the requirements on the print.The observed elemental constituents were found to meet the print requirements for the cutter and the blades.No material or manufacturing defects were found.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: 1.Titanium anchors, which are guided through the cage, engage with the proximal and distal aspects of the implant, and lock into the jacket to maximize segment stability and minimize micro-motion.2.The aero-ll lumbar interbody and fixation system may be used with or without the anchor fixation provided and must be used with additional supplemental fixation that has been cleared by the fda for use in the lumbosacral spine.3.Use the pilot cutter to perforate the cortex and create channels for the anchors.4.Using the mallet, tap the pilot cutter gently to penetrate the cortex and create a channel.A built-in depth stop on the proximal end of the inserter guide limits the depth of the pilot cutter insertion.5.Remove the pilot cutter from the vertebral body by gently tapping the cutter back out of the vertebral body.With the pilot cut made, insert an anchor into the same channel on the inserter guide and into the vertebral body as shown in the anchor insertion step.Once the first anchor is placed and locked into the jacket of the cage, use the same methodology with the pilot cutter and inserter guide to create remaining channel and place the remaining anchors.Anchor insertion: 1.Pull the anchor cartridge from the tray and manually load into the groove of the inserter guide.Downward pressure onto the anchor cartridge releases the anchor from the anchor cartridge.2.Insert the anchor tamp into the groove of the inserter guide and slide downward until it interfaces with a notch on the anchor.Using the mallet, tap the anchor tamp to advance the anchor through the cortex of the vertebral body and engage into the jacket.Per communication with stryker sales representative, patient had concrete bone quality and surgeon attributed much of the event to bone quality of the patient.Risk table states that too much insertion force applied to install anchor can result in anchor damage.Based on available information, most likely cause of reported event is patient's hard bone.

• Brand Name: AERO LL FIXATION ANCHOR, 50MM
• 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: 8447952
• Report Number: 0009617544-2019-00034
• Device Sequence Number: 2746481
• Product Code: OVD
• UDI-Device Identifier: 07613327066173
• UDI-Public: 07613327066173
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151726
• 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): 01/13/2020

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 Catalogue Number: 48940050
• Device Lot Number: 14G499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR