MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 635 TI SI SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179902000
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Patent identifier: (b)(6).Event date is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.A review of the device history record has been requested.Without a lot number, the device history records review could not be completed as no product was received.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) 2021, the patient underwent for a removal surgery due to loosening of set screws.Surgeon's patient had previous posterior spinal fusion surgery.He had to do revision surgery today due to loosening of the 4 set screws.There were no patient consequences.Procedure outcome is unknown.Concomitant device reported: unknown rod (part # unknown, lot # unknown, quantity unknown), unknown screw (part # unknown, lot# b unknown, quantity unknown).This complaint involves four (4) devices.This report is for (1) exp 635 ti si set screw.This report is 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h6: customer quality investigation: this investigation is done based on the supplied image(s).The image(s) was reviewed, and the complaint condition of set screws becoming loose was confirmed as the image(s) showed several set screws being loosened from the rest of spine constructs.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: the dhr of product code: " 179902000", lot : 257158 was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: october 18, 2019 qty: 340.Visual inspection: the exp 635 ti si setscrew (p/n: 179902000, lot number: 257158) was received at us customer quality (cq).Visual inspection of the complaint device showed the threads were stripped and damaged.Attached x-rays showed the set screws had appeared to loosen in the screws.Device failure/defect identified? yes.Functional test: a functional assessment was unable to be performed due to no mating devices returned.The complaint was unable to be replicated.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the x-rays showed setscrews that had loosened in the screws, and the returned device had stripped and damaged threads.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 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.H6: health effect clinician code 2402 used to capture injury.

• Brand Name: EXP 635 TI SI SETSCREW
• 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: 11475548
• Report Number: 1526439-2021-00423
• Device Sequence Number: 3413308
• Product Code: NKB
• UDI-Device Identifier: 10705034084664
• UDI-Public: 10705034084664
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/15/2021

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: 179902000
• Device Catalogue Number: 179902000
• Device Lot Number: 257158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 03/23/2021; 04/02/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/23/2021; 03/24/2021; 04/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; EXP 635 TI SI SETSCREW; UNKNOWN RODS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 86