MAUDE Adverse Event Report: SYNTHES USA; SPINAL VERTEBRAL BODY REPLACE MENT DEVICE

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for (1) 498.32x synex(tm) green cage /unknown lot number.Device is not expected to be returned for manufacturer review/investigation.Concomitant devices: therapy dates are unknown.6.0mm rods (item number unknown, lot number unknown, quantity 2 each); 6.0mm ti collar (item number 498.010, lot number unknown, quantity 8 each); ti nuts 11mm width ((item number 498.003, lot number unknown, quantity 8 each); 6.0mm ti side-opening pedicle screws (item number unknown, lot number unknown, quantity 4 each.).Without a lot number, the device history record review and 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 report that the patient had original surgery on unknown date for treatment to the posterior spine at the t9 -l1 discs levels were the surgeon implanted the (uss) universal spine system for spine fusion with a synex implant that was placed at the t11 disc position.On an unknown date, post-operatively, surgeon reported that the patient had fallen out of a chair.Due to the fall, patient presented with hardware loosening in bone.The t9 screws were reported as cutting into the t9 end disc bone plates.Also, the l1 screws were reported as pulling out of the pedicles over time since the patients fall.Additionally patient was reported as being in pain.On (b)(6) 2017 the patient was brought back to the operating room where she underwent a revision procedure.During revision, surgeon reported that the hardware had loosened in the patient¿s bone.Also, it was observed that the t9 screw had cut into the t9 cranial disc bone endplate and the l1 screws were pulling out of the l1 pedicle bone.During the revision, the surgeon removed that original rods, extended the construct and placed new uss screws at t8, l2, l3, and l4 disc positions.Surgeon removed the t12 screws and chose not replace the screws at this level.Surgeon also removed and replaced the uss screws at t9, t10, and l1 disc positions (6.0mm screws, unknown sizes).The surgeon removed the synex cage placed at t11 ¿(unknown size/ green cage/ 21 x 22 footprint/unknown height).Surgeon reported that there were no mechanical issues with the cage.The cage had migrated the t12 cranial endplate and collapsed into the t12 vertebral body.Surgeon revised the patient at the t12 disc space with a costotransversectomy (corpectomy) and placed a stryker v-lift cage in the t11-t12 space.New rods were implanted.The new uss construct spanned from t8-l4 with no screws implanted at the t11 and t12 disc space.The procedure was successfully completed and patient is reported in stable condition.Patient has retained the implants.Sales consultant has no more information to report on this event.This event is for three (3) devices: 1 synex(tm) green cage; 2 6.0mm screws migrated; 2 6.0mm screws loose.Concomitant devices: 6.0mm rods (item number unknown, lot number unknown, quantity 2 each); 6.0mm ti collar (item number 498.010, lot number unknown, quantity 8 each); ti nuts 11mm width ((item number 498.003, lot number unknown, quantity 8 each); 6.0mm ti side-opening pedicle screws (item number unknown, lot number unknown, quantity 4 each.).This report is 1 of 3 for (b)(4).

• Type of Device: SPINAL VERTEBRAL BODY REPLACE MENT DEVICE
• 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: 6853656
• MDR Text Key: 85577436
• Report Number: 2520274-2017-12231
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/17/2017

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/08/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR