MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO-LL LUMBAR CAGE SYSTEM 10X50MMX8DEG - 18; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48941210
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the anchors did not seat correctly in the interbody spacer.Update 10/27/2017: patient will undergo a revision surgery on (b)(6) to install supplemental fixation system (screws and rods).
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via correspondence with the sales representative.The removed anchors were discarded by the physician and not available for evaluation.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Based on additional correspondence between the sales representative and the surgeon, the most likely cause of the reported event was determined to be the wrong size of inserter guide picked by the hospital staff in error.The reported event resulted in a secondary surgery, not a revision surgery as initially reported.The supplemental fixation system was supposed to be installed initially.Per the instrument's surgical technique guideline: "with the anchors inserted and locked in place, supplemental fixation that has been cleared by the fda approved for use in the lumbosacral spine must be used to augment stability of the construct.".
Event or Problem Description
It was reported that; the anchors did not seat correctly in the interbody spacer.Update 10/27/2017: patient will undergo a revision surgery on (b)(6) to install supplemental fixation system (screws and rods).

• Brand Name: AERO-LL LUMBAR CAGE SYSTEM 10X50MMX8DEG - 18
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6991309
• Report Number: 0009617544-2017-00391
• Device Sequence Number: 1379276
• Product Code: MAX
• UDI-Device Identifier: 07613327066050
• UDI-Public: (01)07613327066050
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K142066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2018

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: No Information
• Device Model Number: 48941210
• Device Catalogue Number: 48941210
• Device Lot Number: 14G605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 02/25/2018
• 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: 55 YR