MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE PRODUCT

Catalog Number UNK_SPN

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2016

Event Type  malfunction  

Event Description

It was reported that the surgeon performed an occiput-t2 revision/extension to t3.There was a fractured c1 smooth shank screw (3.5x28mm) in which the tulip head was completely displaced from the shank.During the revision surgery, after gaining access, the surgeon proceeded to remove 18 total blockers from the construct.He verbally noted that multiple blockers were loose upon removal.He then removed both vitallium rods (2 offset connectors included).After removing his rods he had to fish out the screw threading of the c1 smooth shank screw that was fractured.

Manufacturer Narrative

Risk assessment.The device was not returned and no lot # was provided, so a manufacturing record review could not be performed.Per the surgical technique, "delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.", the surgical technique also states, "while the expected life of spinal implant components is difficult to estimate, it is finite." as the tulip was also found to have disengaged, this further supports the root cause of loading cycles causing the device failure.The most probable root cause of the failure is additional and repetitive stresses placed on the construct from the lack of fusion.

Event Description

It was reported that the surgeon performed an occiput-t2 revision/extension to t3.There was a fractured c1 smooth shank screw (3.5x28mm) in which the tulip head was completely displaced from the shank.During the revision surgery, after gaining access, the surgeon proceeded to remove 18 total blockers from the construct.He verbally noted that multiple blockers were loose upon removal.He then removed both vitallium rods (2 offset connectors included).After removing his rods he had to fish out the screw threading of the c1 smooth shank screw that was fractured.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN SPINE PRODUCT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5984822
• MDR Text Key: 56333997
• Report Number: 0009617544-2016-00386
• Device Sequence Number: 1
• Product Code: MNI
• 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: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2016
• 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: 72 YR
• Patient Weight: 64