MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI POLY SCREW 8MMX50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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 the patient has a posterior spine construct from t10-ilium.The construct is two constructs attached with connectors.The upper construct is t10-l2 synthes uss dual opening and is connected with expedium rod to rod connectors just below l2 and connects to a depuy expedium 5.5mm rod construct from l3-ilium.Dr.(b)(6) said that the lumbar portion of the construct was placed in 2015.The issue is that according to dr.(b)(6) the patient has a non-union at l5-s1.The patient's rods broke bilaterally between the l5 and s1 screws.On (b)(6) 2019 dr.(b)(6) performed the revision.During the revision, dr.(b)(6) removed the left and right expedium rods that were connected to the depuy rod to rod connectors.It appears that the left and right rods were cut from a single 480mm cobalt chrome rod - 196789480.There was no visible serial # on the rods.Both were broken.Dr.(b)(6) then switch out the right l5 screw that was loose.He removed a 7.5mm x 50mm expedium poly screw 179712050.He then inserted a 8.0 x 50mm (179712850) to the same screw hole.There was a tremendous amount of torque needed to insert the screw.Before getting the screw fully seated, the driver tip on the screwdriver broke off in the screw.Dr.(b)(6) then cut a short rod and placed a locking cap into the screw to secure the rod.He torqued the locking cap.He then used the expedium countertorque to try and "helicopter" the screw out.This did not work.The screw head rotated, but did not back the screw out.Dr.(b)(6) then used a metal cutting burr to cut the head off of the screw so that he could place a rod.Because the screw was elevated above the level of the other screws, a rod could not be placed - this screw would get in the way.He successfully cut the screw head off along with the top of the screw that contained the broken driver tip.Dr.(b)(6) then cut and contoured 2 new rods.He then placed them in the rod to rod connectors attached to the upper rods.He then placed new expedium locking caps to connect the rods from l3-ilium.He successfully completed the procedure.No other information is available.No patient height or weight available.No images available.Only part coming back to quality unit is the 2797-12-400.It is available to return.I need a replacement for this part.

• Brand Name: EXP TI POLY SCREW 8MMX50MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8282791
• Report Number: 1526439-2019-51283
• Device Sequence Number: 16658341
• Product Code: NKB
• UDI-Device Identifier: 10705034068084
• UDI-Public: (01)10705034068084
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101993
• 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): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179712850
• Device Catalogue Number: 179712850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR