MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OIC PEEK SIZE 9 MM - 4DEG - L20 MM; IMPLANT- SPACER

Catalog Number 673094

Device Problems Loose or Intermittent Connection (1371); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2013

Event Type  malfunction  

Event Description

It was reported that."on (b)(6) 2013, it was found that ser screw was loose, still in the screw head, and one of two cage in between l5 and s was out of the position.On (b)(6) 2013 cage was removed from the patient.".

Manufacturer Narrative

Method: photographic inspection; device history review.Results: no x-rays/photos are available.Product was not returned (disposed).A root cause cannot be determined (multi factorial).Not enough information was received.Further patient information could not be obtained, but it should be noted that other factors that can impact the success of union are obesity, smoking, and patient pathologies.A list of questions was sent out to the sales rep for more information about the patient (adverse consequences, activity level, injury, ect.), but answers were mostly unknown.Conclusion: the exact cause cannot be determined without a product to inspect.

Manufacturer Narrative

Method: complaint history review; risk assessment.Results: the oic peek cage was indicated to have migrated according to the event description, however the product was not returned.Manufacturing records could not be reviewed because the lot # for the involved device is unknown.Previous investigations have shown that main causes of cage migration post op are if the patient is involved in an occupation or activity that applies excessive loading upon the implant (e.G., substantial walking, running, lifting, or muscle strain), resulting in increased risk for failure of the fusion and/or the device.However, it is not known if the patient experienced a trauma or participated in strenuous activity.The exact cause cannot be determined and is likely multifactorial in nature.Conclusion: the exact cause cannot be determined and is likely multifactorial in nature.

Event Description

It was reported that."on (b)(6) 2013, it was found that ser screw was loose, still in the screw head, and one of two cage in between l5 and s was out of the position.On (b)(6) 2013 cage was removed from the patient.".

• Brand Name: OIC PEEK SIZE 9 MM - 4DEG - L20 MM
• Type of Device: IMPLANT- SPACER
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3775253
• MDR Text Key: 4442375
• Report Number: 0009617544-2014-00181
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2013

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
• Device Operator: Health Professional
• Device Catalogue Number: 673094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2013
• Initial Date FDA Received: 04/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 75