MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199723860S

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code : kwp, kwq.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was found that the screws which were deployed in the right ilium had come off the rod.He underwent for a revision surgery for rod fusion, and it was confirmed that remaining screws had not been loose.The plf revision procedure was performed to extend the fusion range up the ilium on (b)(6) 2021.The procedure was completed less than 30-minute delay.The patient outcome was unknown.Concomitant device reported: unknown set screw (part # unknown, lot # unknown, quantity unknown), unknown tightener (part # unknown, lot # unknown, quantity unknown), unknown rod holder (part # unknown, lot# unknown, quantity unknown), 5.5 exp verse unitized set scr (part # 199721001s, lot # xp1233, quantity 1), single-inner set screw (part # 179702000, lot # 286895, quantity 1).This complaint involves four (4) devices.This report is for (1) 5.5 exp verse fen scr 8.0 x 60.This report is 3 of 3 (b)(4).Related product complaint: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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: h11: d1; brand name.D2: additional product code : osh, mni, mnh.D4: part number, lot# & udi updated.G1: manufacture site.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.D1; brand name.D2: additional product code : osh, mni, mnh.D4: part number, lot# & udi updated.G1: manufacture site.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that single-inner setscrew component threads were slightly deformed.The dimensional inspection was not performed due to the post-manufacturing damage.The complete functional test cannot be performed as all mating devices were not returned and components in the received device were damaged.The observed condition of the single-inner setscrew component in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed deform condition of the single-inner setscrew component would contribute to the complained loose issue.While no definitive root cause could be determined, it is probable that the single-inner setscrew is deformed due to the unintended.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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 179702000 lot : 286895 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 29.09.2020 qty: 1335 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.G4.

Manufacturer Narrative

Product complaint # (b)(4).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: h3, h6: the device was 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.

• Brand Name: EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5
• Type of Device: 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: 11740288
• MDR Text Key: 249033326
• Report Number: 1526439-2021-00818
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034444291
• UDI-Public: 10705034444291
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 199723860S
• Device Catalogue Number: 179702000
• Device Lot Number: 286895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 04/30/2021; 06/07/2021
• Supplement Dates FDA Received: 05/27/2021; 05/28/2021; 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE FEN SCR 8.0X60.; SINGLE-INNER SETSCREW.; UNKNOWN LOCKING/SET SCREWS.; UNKNOWN ROD HOLDER.; UNKNOWN RODS.; UNKNOWN TIGHTENER.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR