MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK TRITANIUM PL 9MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48955096
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon shaved the disc space to 9mm.The cage was used on the 11mm inserter.The rep confirmed the implant was on firmly.The surgeon was very cautious when hitting the inserter with the mallet.Upon insertion, the graft was inserted half way into the disc space and the graft broke while in the patient.2/3rds of the graft that broke off into the patient was impacted and left inside the patient.The piece that was on the inserter will be returned.First time, the surgeon used tritanium and nothing was done out of the ordinary.He did not insert the graft under distraction.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.There was evidence of (1) insufficient distraction prior to implant insertion, (2) a particularly small and collapsed patient's disc space and the moderately hard patient's bone quality, and (3) no observation of asymmetric wear mark indicating of the misaligned insertion force, conclusion: the potential root cause of the reported event was likely due to be compression force due to interference of the vertebra body in relation to the insertion force.
Event or Problem Description
It was reported that; the surgeon shaved the disc space to 9mm.The cage was used on the 11mm inserter.The rep confirmed the implant was on firmly.The surgeon was very cautious when hitting the inserter with the mallet.Upon insertion, the graft was insertered half way into the disc space and the graft broke while in the patient.The 2/3rds of the graft that broke off into the patient was impacted and left inside the patient.The piece that was on the inserter will be returned.First time the surgeon used tritanium and nothing was done out of the ordinary.He did not insert the graft under distraction.

• Brand Name: TRITANIUM PL 9MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• MDR Report Key: 5877279
• Report Number: 0009617544-2016-00334
• Device Sequence Number: 10850802
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: (01)07613327118070
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: 48955096
• Device Lot Number: A97Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• Supplement Report FDA Received Date: 09/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1