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

Catalog Number UNK_SPN

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348)

Event Date 06/14/2012

Event Type  malfunction  

Event Description

It was reported by a lawyer that the patient, due a domestic accident on (b)(6) 2011, underwent an emergency arthrodesis.After a year, both stabilization bars are broken.The patient asked to an expert to do an assessment about the event and in the report which is as specified: "without other accidental events such as another fall, even trivial, after almost a year both fixing and stabilizing bars broke at the same level in a spontaneous way.All this caused the execution of two additional surgeries, the first complicated by a modest infection of the surgical wound and a fracture of the anterior inferior portion of the 12th thoracic vertebra (indicated by mri performed on (b)(6) 2012 and confirmed by that performed dated (b)(6) 2013) for the appearance of a kyphosis d12-l1.Although the breakdown of the synthesys devices is a fact that can complicate operations such as those suffered by (b)(6), his young age, lack of previous vertebral malformations, the absence of additional traumatic events and the correct implementation of the action, suggest that the aforementioned break is at least attributable to a structural failure of the fixation rods, failure most likely attributable to the absence of production and / or intrinsic defect of the same metallic materials.All this caused an unjust and therefore compensable harm to the person causing a greatest period of illness, a greater biological damage of a permanent nature, more psycho-physical suffering and not minimum healthcare costs." the lawyer asks the pecuniary and non-pecuniary damages.

Manufacturer Narrative

Risk assessment; device history review, device evaluation, complaint history review could not be performed as the reported device was not properly identified.The event could not be confirmed nor the root cause of the reported event determined because no device and/or insufficient information was provided for review.

Event Description

It was reported by a lawyer that the patient, due a domestic accident on (b)(6) 2011, underwent an emergency arthrodesis.After a year, both stabilization bars are broken.The patient asked to an expert to do an assessment about the event and in the report which is as specified: "without other accidental events such as another fall, even trivial, after almost a year both fixing and stabilizing bars broke at the same level in a spontaneous way.All this caused the execution of two additional surgeries, the first complicated by a modest infection of the surgical wound and a fracture of the anterior inferior portion of the (b)(6) thoracic vertebra (indicated by mri performed on (b)(6) 2012 and confirmed by that performed dated (b)(6) 2013) for the appearance of a kyphosis d12-l1.Although the breakdown of the synthesys devices is a fact that can complicate operations such as those suffered by (b)(6), his young age, lack of previous vertebral malformations, the absence of additional traumatic events and the correct implementation of the action, suggest that the a formentioned break is at least attributable to a structural failure of the fixation rods, failure most likely attributable to the absence of production and / or intrinsic defect of the same metallic materials.All this caused an unjust and therefore compensable harm to the person causing a greatest period of illness, a greater biological damage of a permanent nature, more psycho-physical suffering and not minimum healthcare costs." the lawyer asks the pecuniary and non-pecuniary damages.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNWON 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6031556
• MDR Text Key: 57926413
• Report Number: 0009617544-2016-00415
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• 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: 46 YR