MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 4.5 TI SINGLE INNIE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186100001
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.(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, during growing rod lengthening procedure, after exposure of the original existing hardware, the surgeon determined that the interface between the wedding band connector and the rod was loose.The surgeon could immediately tell that the single innie set screw locked into the connector on the open side of the 4.5 / 4.5 connector was stripped and cross threaded.He then attempted to implant a new single innie set screw which immediately cross threaded, removed that set screw, and also the original 4.5 / 4.5 connector.Then used in-situ benders to adjust the rod and implanted a new connector and determined that the original was damaged.There was a surgical delay of ten (10) minutes.There were no fragments generated.There were no patient consequences.The procedure was successfully completed.Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity unknown); exp 4.5 ti op/clsd 4.5x4.5 (part#: 186172345, lot#: unknown, quantity 1).This report is for one (1) exp 4.5 ti single innie.This is report 1 of 2 for (b)(4).This complaint will capture the intra-op event (attempted to implant a new single innie set screw which immediately cross threaded) while (b)(4) will capture the post- op event (loosening of the interface between the wedding band connector and the rod, single set innie screw was stripped and crossed threaded, infection was present).

• Brand Name: EXP 4.5 TI SINGLE INNIE
• 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: 9812368
• Report Number: 1526439-2020-00674
• Device Sequence Number: 11485627
• Product Code: MNI
• UDI-Device Identifier: 10705034103846
• UDI-Public: (01)10705034103846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186100001
• Device Catalogue Number: 186100001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR