MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number UNK_SPN

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/21/2015

Event Type  Injury  

Event Description

It was reported; dr.Had stated he implanted oasys screws in t11-l2, however i filled out inventory sheet for xia 2 in pt records.Gave him tech guides for both oasys and xia 3 to prove oasys is for cervical and xia for lumbar.I felt dr.Got systems confused on accident.Case was dictated he used 4.5mmx45mm int11 and he had to use 5.5mmx50mm screws for l2 cuz we didn't have 4.5 mm x 50mm in house.Found out pt had a blocker that came loose from construct and was free floating and had revision surgery else where.

Manufacturer Narrative

Method: device not returned; results: device history review could not be performed as device was not properly identified.The ifu states; "the use of the polyaxial screws is limited to placement in the upper thoracic spine (tl -t3).They are not intended to be placed in the cervical spine.The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (c i-t3) spine." conclusion: the plausible root cause is user error, specifically deviation from user instructions.

Event Description

It was reported; dr.Had stated he implanted oasys screws in t11-l2, however i filled out inventory sheet for xia 2 in pt records.Gave him tech guides for both oasys and xia 3 to prove oasys is for cervical and xia for lumbar.I felt dr.Got systems confused on accident.Case was dictated he used 4.5mmx45mm int11 and he had to use 5.5mmx50mm screws for l2 cuz we didn't have 4.5 mm x 50mm in house.Found out pt had a blocker that came loose from construct and was free floating and had revision surgery else where.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4525337
• MDR Text Key: 16182525
• Report Number: 0009617544-2015-00070
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2015
• 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 Outcome(s): Required Intervention