MAUDE Adverse Event Report: SYNTHES MEZZOVICO ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Catalog Number 04.617.127S

Device Problems Fitting Problem (2183); Component or Accessory Incompatibility (2897)

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

Event Type  Injury  

Event Description

It was reported that a zero-p cervical spine locking screw backed-out, as per x-rays taken on an unknown date.The patient was originally implanted with the zero-p implant at c3-c4 in (b)(6) of 2014.Although the patient was not experiencing any symptoms, x-rays were taken, which confirmed that the screw had backed-out.The screw was described as having "moved back, then stopped." on (b)(6) 2015, the patient underwent an anterior cervical discectomy fusion (acdf) procedure during which the entire construct, consisting of one (1) zero-p implant and four (4) 3.0 x 14mm cervical spine locking screws, was removed.The right middle backed-out screw was removed and separated from the other screws.There were no issues with the other three screws.The patient was revised to a zero-p variable angle (va) implant.There were no surgical delays and the procedure was successfully completed.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: patient initials are (b)(6) and he is listed as being (b)(6).Date of postoperative screw movement is unknown.Original implant procedure was on an unknown date in (b)(6) 2014.Subject device has been received; no conclusion could be drawn as the product is entering the complaint system.Device history review: manufacturing location: (b)(4) - manufacturing date: february 6, 2013 - expiry date: february 1, 2023.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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

Product investigation summary: five (5) implants [one zero-p spacer (part 04.617.127s, lot 8250643), and four (4) 3.0mm ti cervical spine locking screws (part 04.617.814] belonging to the zero-p stand alone spacer system were returned with the complaint that ¿a zero-p cervical spine locking screw was discovered via x-rays to have backed-out and the patient underwent a revision surgery to have it removed.¿ upon receipt of these devices, it was seen that these implants have minor scratches and cosmetic markings consistent with implantation and being explanted.The ti and peek components of the spacer were separated, but this likely occurred during the explant process or during decontamination.The device is not broken and can be reassembled.No x-rays were received to confirm this complaint.It is recommended, per the technique guide, that a torque limiting attachment be used for locking the screws into the spacer, and it is unknown if it was used during insertion to ensure that the construct was secure.The drawings for these devices were reviewed.The designs, materials, and finishing processes were found to be adequate for the intended use of these devices.The returned implants conform to the device drawings.This complaint could not be confirmed due to the lack of x-rays.The root cause is undetermined; however, if a tla was not utilized as recommended per the technique guide, that may have contributed to this complaint.The designs of these devices are adequate for their intended uses and did not contribute to this complaint.Device 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

Device was used for treatment, not diagnosis.Based on additional information received on feb 9, 2016, this complaint event re-reviewed for reportability and it was determined that the additional information reasonably suggests that a device malfunction did occur and regardless of misuse, has caused or contributed to the need for medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.This event required additional surgical intervention.The initial medwatch report, (b)(4), had reported this event as a product problem/malfunction only based on the event information available at the time of the initial report.(b)(4).Added for revision surgery due to implant failure and non-union, pain and pseudoarthrosis.Device code was corrected for implant loosening.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on february 9, 2016.It was reported that the patient underwent a revision surgery on (b)(6) 2015 due to pseudoarthrosis at c4-5 and a fracture at c5 that pushed bone fragments into the spinal canal and required a partial corpectomy and arthrodesis.In addition, the plate of the zero-p implant was loose and a screw had migrated anteriorly.The patient had some neck pain, a little bit of arm pain, and also dysphagia.The patient's initial anterior cervical interbody fusion (acif) surgery at c4-c5 was performed on (b)(6) 2015.

Manufacturer Narrative

The awareness date for the previous medwatch was submitted in error as february 9, 3016.The correct date of awareness was february 9, 2016.Device 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.

• Brand Name: ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4630541
• MDR Text Key: 5616216
• Report Number: 1000562954-2015-10082
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: 04.617.127S
• Device Lot Number: 8250643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109