MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 7 X 50MM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number	179799750
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2020, the patient underwent revision spinal surgery treating l4-s1.The surgeon experience difficulty removed the s1 screw as the driver was unable to effective engage with the screw.The screw was found the be stripped and worn down.The screw head was eventually mobilized and enabled removal of the screw.The procedure was successfully completed.There was no surgical delay.There was no patient consequence.This report is related to (b)(4).This report is for one (1) expedium spine system di favored angle reduction screw 5.5 x 7 x 50mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional procode: nkb, kwp, mnh, mni, kwq.Investigation summary visual inspection: the exp di far screws 7.00 x 50 (p/n:179799750, lot number: atmc4v) was received at us cq.Upon visual inspection of the complaint device showed screw head severely stripped/worn out.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the complaint device was received with severely stripped/ worn out head.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot, part number: (b)(4), lot number: (b)(4), supplier: medos, batch# 1: release to warehouse date: nov 11, 2015, no ncr's were generated during production.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.

• Brand Name: EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 7 X 50MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL CH; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13170981
• Report Number: 1526439-2022-00021
• Device Sequence Number: 4619973
• Product Code: OSH
• UDI-Device Identifier: 10705034083834
• UDI-Public: 10705034083834
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 179799750
• Device Catalogue Number: 179799750
• Device Lot Number: ATMC4V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWDRIVERS
• Patient Sex: Unknown