MAUDE Adverse Event Report: SYNTHES MONUMENT TI LOCKING SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.508

Device Problem Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information reported.It is unknown when device malfunctions occurred.This report is for unconfirmed/unknown quantity of unknown locking caps (udi) no part number, udi unavailable.Original implant date(s) are unknown; it is unknown if the device(s) were explanted and if so what date the devices were explanted.Device(s) are unavailable for return.Unknown therapy date.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.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 a surgeon identified a total of three (3) possible synapse locking cap failures in multiple unknown cases.It is unknown when the devices were implanted and when or if the devices were explanted.It was clarified that it was identified postoperatively that the devices loosened.Concomitant devices reported: synapse 4.0mm screws (part #: unknown, lot #: unknown, qty.Unknown); synapse 4.0mm rods (part #: unknown, lot #: unknown, qty.Unknown) this report is for unconfirmed unknown quantity of locking caps this is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Corrected data: common name and device code.Additional device codes: kwp, mnh, mni.Part number udi: (b)(4).Lot number unknown.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 a surgeon identified a total of three (3) possible synapse locking cap failures in multiple unknown cases.It was clarified that it was identified postoperatively that the devices loosened from the screw and either came off completely from the screw head, or loosened and slid off of the rod either cranially or caudally.Concomitant devices reported: synapse 4.0mm screws (partial part 04.615.Xxx, lot number unknown, quantity unknown); synapse 4.0mm rods (partial part 04.615.Xxx, lot number unknown, quantity unknown).

Manufacturer Narrative

Additional patient identifier: (b)(6).Serious injury added.Updated information obtained.Additional product codes: kwp, mnh, mni.Lot number provided, udi updated.Returned to manufacturer.Concomitant devices updated.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 a patient underwent a c2-t2 posterior cervical fusion procedure using the synthes 4.0mm synapse system on (b)(6) 2017.Postoperatively, it was identified that a total of three (3) synthes titanium (ti) locking screws had loosened, and two (2) of the screws were free floating above the head of the implanted synapse 4.0mm screws.On (b)(6) 2017, the patient was returned to the operating room where the complained devices along with the remaining implanted devices were removed easily and the surgeon revised the patient using the synapse and synthes universal spine system (uss) screws and rods.The construct was extended to cover c2-t4.The procedure was completed successfully and the patient was reported to be stable.Concomitant devices reported: synapse 4.0mm screws (part 04.615.232, lot number unknown, quantity 2); synapse 4.0mm rods (part 04.615.526, lot number unknown, quantity 2).

Manufacturer Narrative

Device history records review was completed for part# 04.614.508, lot# h185684.Manufacturing location: monument, manufacturing date: oct 19, 2016.Component lot h040185, part bk100018 blank, 9.5mm ti w/t15.Finished lot machined and certified by general machine inc.The product has been certified and acceptable per requirements.Component lot h040185, part number bk100018, date of manufacture: july 27, 2016.The component was machined and certified by universal punch.The product has been certified and acceptable per requirements.Raw material lot 7009843, part 21039, tialnbri9.50.Material certified by perryman company and all requirements were met.Raw material receiving/putaway checklist meet specification.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this 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

Customer quality conducted an investigation of the returned devices.Two ti locking screws were returned and no defects or deficiencies were identified which may have contributed to the complaint condition; the threads which interact with the polyaxial head were found to be well defined and without deformation.Additionally available x-rays were reviewed where the complaint condition was unable to be confirmed.As no issues were identified with the devices/x-rays, the complaint is unable to be replicated and is unconfirmed.The following implants were additionally returned without allegation: 04.615.526, lot 9897197, 04.615.526, lot l146883, 04.615.232, lot h15388, 04.615.230, lot h226907.The devices were examined and no defects or deficiencies were identified other than minor surface finish wear which can be attributed to implantation and explantation.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, drawing review, complaint history review and device history review were performed as part of this investigation.No product design issues or discrepancies were observed.The ti locking screw (04.614.508) is a component of the synapse system which provides posterior stabilization to the occipito-cervico-thoracic spine.The system contains top loading polyaxial screws and hooks which interact which form a construct when paired with 4.0mm titanium rods and locking screws.Following polyaxial screw and/or hook placement and rod insertion, the ti locking screws can be inserted and finial tightened using a 2.0nm torque limiting handle (03.614.035).The returned ti locking screws were examined and no defects or deficiencies were identified which may have contributed to the complaint condition; the threads which interact with the polyaxial head were found to be well defined and without deformation.Additionally available x-rays were reviewed where the complaint condition was unable to be confirmed.As no issues were identified with the devices/x-rays, the complaint is unable to be replicated and is unconfirmed.Relevant drawings for the returned devices were reviewed (both current revision and from the time of manufacture): top-level.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable as the complaint condition was unable to be replicated.A device history review, including material review, was performed for the returned implant¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.This complaint condition is adequately covered by the risk assessment.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.

• Brand Name: TI LOCKING SCREW
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6629310
• MDR Text Key: 77621367
• Report Number: 2520274-2017-11782
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/12/2017

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?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.614.508
• Device Lot Number: H185684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 07/10/2017; 11/03/2017; 11/21/2017; 01/04/2018
• Supplement Dates FDA Received: 07/10/2017; 11/20/2017; 12/19/2017; 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 98