MAUDE Adverse Event Report: SYNTHES USA; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Stenosis (2263); Neck Pain (2433); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is not provided for reporting.This report is for one (1) unknown zero-p va - 9 mm.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.The (510k): unknown, as specific part and lot numbers for zero-p va - 9 mm is not provided.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient is suffering; has pain, limited cervical range of motion, and swelling causing problems swallowing.On (b)(6) 2016, the patient underwent a cervical spine revision due to a herniated disc at c4-5 and bilateral left greater than right cervical radiculopathy.It was noted during the procedure that the patient had solid arthrodesis at c5-c6, and had central fragments of subligamentous soft disc herniation throughout the central ventral spinal canal.Although the patient has solid arthrodesis, he has had severe neck pain and bilateral upper extremity symptoms largely left-sided, but more recently affecting the right side in the c5 distribution.Imaging shows progression of herniated disc at c4-c5 causing central and foraminal stenosis.The surgeon removed two (2) screws from the zero-p va implant which was implanted on (b)(6) 2014 at c5-c6 and left the remainder of the implant in the patient.The screws were removed so they would not interfere with the placement of new hardware.The surgeon then performed a c4-c5 anterior cervical discectomy with microsurgical foraminotomies and then implanted an unknown non-synthes 7 mm allograft bone implant with iliac bone graft harvest, a non-synthes plate, and an unknown quantity of unknown 14 mm cortical screws.There were no complications and no surgical delay during the procedure.Patient outcome was stable.This complaint is linked with (b)(4), which captures the postoperative device malfunction from the initial procedure in (b)(6) 2014.Concomitant devices reported: unknown 7 mm musculoskeletal transplant foundation (mtf) allograft bone implant (quantity # 1), depuy skyline cervical plate (quantity # 1), unknown 14 mm cortical screws (quantity # 4).This report is for one (1) unknown zero-p va - 9 mm.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

The zero-p va system (j9912-d) offers variable angle zero-profile anterior cervical interbody fusion (acif) solutions using a stand-alone implant which combines the functionality of a cervical interbody spacer and the benefits of an anterior cervical plate.The subject zero-p va implants were not returned, but reported info regarding the patient/procedures was used to confirm the complaint condition, and made its replication inapplicable.Since a definitive part/lot combo was not available for the subject implants, a dhr review could not be completed, and since the parts were not returned neither a drawing review, nor dimensional/material/hardness checks will be completed as part of this investigation.Based on the available information it is not possible to determine a definitive root cause for the complaint condition, but there is no indication that it occurred due to a product related issue.There are multiple factors that can impact the post-operative outcome and adversely impair the healing process.Diseases such as, but not limited to, hereditary predispositions, osteoporosis, diabetes, obesity and rheumatoid arthritis as well as comorbidities such as alcohol, tobacco and drug use impair patients¿ ability to heal which could have contributed to the complaint condition.It is also possible that a complication during the initial procedure could have contributed to the complaint condition, but that was not able to be definitively determined using the available information.During the investigation, no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Corrected data: not explanted, implant remains in the patient.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6876436
• MDR Text Key: 86621188
• Report Number: 2520274-2017-12287
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 09/19/2017; 10/20/2017
• Supplement Dates FDA Received: 09/19/2017; 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALLOGRAFT BONE IMPLANT (PART & LOT UNK, QTY 1); CORTICAL SCREWS (PART UNKNOWN, LOT UNKNOWN, QTY 4); PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1
• Patient Outcome(s): Required Intervention