MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 8X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186731850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code kwp; kwq; mnh; mni.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 or Problem Description
It was reported that on (b)(6) 2020, the surgeon was revising a patient with expedium 5.5 implants (construct bilaterally from t11-pelvis) originally implanted on (b)(6) 2018.The patient suffered from pseudoarthrosis, with the appearance of pedicle screws loosening at t11 and l1 (bilaterally), s1 (right pedicle) and bilateral s2 iliac bolts.The set screws at l5, s1 and the iliac screw on the patient's left side loosened, and the s1 set screw had become dislodged from the polyaxial head.The surgeon removed the t11 and l1 pedicle screw bilaterally and replaced each with 7.5 x 45mm screw.Before placing the new pedicle screw, the surgeon tapped the original screw trajectory the full length of the new screw (45mm) with a 7mm tap and placed the new screws successfully.The surgeons then removed the s1 pedicle screw on the right side (7.5 x 45mm screw).The surgeon felt the pathway of the removed screw and used the pedicle probe to further cannulate s1 (r) to the anterior cortex at 50mm and determined it would be replaced with an 8.0 x 50mm screw for adequate purchase.They then used an 8.0mm tap to tap the full length of the screw, 50mm and confirmed the depth with a ball tip probe.When they inserted the screw, the tip of the t20 quick-connect driver broke off in the recess of the polyaxial screw before the surgeon could fully seat the implant.With the broken tip lodged in the screw, they did not have an option to re-engage the implant and had to leave the screw approximately 5 mm proud of the intended implant position.This later affected rod placement and the s1 screw's (r) polyaxial head did not align with the rest of the construct.The surgeon placed an iliac connector to correct for the proud s1 screw.Fragments were generated with the tip of the t20 driver could not be dislogned from the implant.The procedure was successfully completed.There is a surgical delay of ten (10) minutes.The patient status is unknown.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown).Unknown setscrew (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

• Brand Name: 5.5 TI CORT FIX 8X50MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10153749
• Report Number: 1526439-2020-01177
• Device Sequence Number: 11212659
• Product Code: NKB
• UDI-Device Identifier: 10705034352206
• UDI-Public: 10705034352206
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: 186731850
• Device Catalogue Number: 186731850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention