MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI POLY SCREW 8MMX90MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: kwp; kwq; mnh; mni.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 patient had hardware from t5-ilium.There was no screw in l1 and an extension connector connecting the upper and lower rod.The surgeon thought that the previous surgery was on an unknown day in (b)(6) 2019.The surgeon said that the patient has a non union at l5-s1.At an unknown point in time the patient broke the following hardware: left iliac screw, right iliac screw, left s1 screw.These screws were all broken right at the base of the screw heads.The surgeon performed the revision on (b)(6) 2020 and removed the caudal rods that were in the extension connector and then replaced all the screws from l2-ilium.The devices were all unknown sizes except the broken ones described above.The surgeon was also able to retrieve and remove the broken screw shafts in the iliac screws and left s and replaced all the l2-s1 screws with expedium screws and replaced the iliac screws with viper sai fully threaded screws.The surgeon then contoured new rods and placed new extension connectors on the cranial rod and placed and tightened the new caudal rods onto the extension connector and connected all the l2-ilium screws to the new expedium / sai screws.The procedure was successfully completed without surgical delay.There was no patient consequence.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown).Unknown setscrews (part# unknown, lot# unknown, quantity unknown).Unknown extension connector (part# unknown, lot# unknown, quantity unknown).This report is for one (1) exp ti poly screw 8mmx90mm.This is report 2 of 3 for (b)(4).

• Brand Name: EXP TI POLY SCREW 8MMX90MM
• 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: 10773376
• Report Number: 1526439-2020-02081
• Device Sequence Number: 19836294
• Product Code: NKB
• UDI-Device Identifier: 10705034068169
• UDI-Public: (01)10705034068169
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 179712890
• Device Catalogue Number: 179712890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91