MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONSTRAINED, SELF-TAPPING SCREW 4.0X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186862014

Device Problem Device Slipped (1584)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Original dos (b)(6) 2016.Surgeon performed a cervical 4-7 surgery.A stryker interbody was placed at c4-5 interbody space, a c6 corpectomy was performed and a bengal monolithic cage 28mm lordotic.A skyline 51mm 3 level was placed c4-7.The 14mm variable screws were placed at c4, 16mm variable screws were placed at c5, 14mm constrained screws were placed at c7.On (b)(6) 2016 i was notified by dr (b)(6) nurse that the patient had a screw that seemed to be backing out a c7.It appears to be out 3.5 mm.Plan is to bring patient back to or on (b)(6) 2016 to remove screw or revise construct and he may be adding on c7-t1 as well.

Manufacturer Narrative

Additional narrative: (b)(4).One (1) constrained s-t screw, 14mm was returned for evaluation.Visual examination of the screw revealed signs of wear and tear from operative usage.No other defects were identified.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.In general, patient factors that may affect the performance of the components include: patient anatomy, bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto are unknown.With the provided information, the investigation could not confirm any alleged product failure as there is no evidence of damage to the returned products.It is not suspected that the product failed to meet specifications.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONSTRAINED, SELF-TAPPING SCREW 4.0X14MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6159345
• MDR Text Key: 62092239
• Report Number: 1526439-2016-10918
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186862014
• Device Lot Number: AMKBRN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HYBRID THREE LEVEL PLATE,51MM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR