MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721001S

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2018, an original posterior spinal fusion was performed treating spinal stenosis by stabilizing l2-l5.On (b)(6) 2019, an extension procedure for intervertebral fusion was performed due to asd (adjacent segment disease).It was found that the set screw (199721001s) implanted on the l4 right had come off.Also, the set screw (unk) on the l5 right was loose.The procedure was completed without a surgical delay.No further information is available.This complaint involves two (2) device.

Manufacturer Narrative

Product complaint # (b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.

Manufacturer Narrative

(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.The threads of the device are stripped/worn.There is light discoloration on both the threads and the screw head.Due to the damage to the screw¿s threads the device is inoperable.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.Although no definitive root-cause can be determined, the set screw may have experienced unintended forces such as over-torque during implantation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H6: code 3191 used to capture medical device removal only.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.

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 review of the receiving inspection (ri) for 5.5 exp verse unitized set scr was conducted identifying that lot number vh1233 was released in a single batch.Batch1: released on june 30, 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the 5.5 exp verse unitized set scr was received at us customer quality (cq).The threads of the device are stripped/worn.There is light discoloration on both the threads and the screw head.Due to the damage to the screw¿s threads, the device is inoperable.Functional test: no relevant mating devices were returned/available for functional testing however, due to the damage to the threads, the screw would not be able to function as intended.The reported condition of functional loose is confirmed due to the observed damage.The overall complaint is confirmed.Dimensional inspection: measured dimensions: major diameter = conforming.Document/specification review: drawing(s) reviewed: current & manufactured revisions.Conclusion: the overall complaint was confirmed for the received 5.5 exp verse unitized set scr as the device¿s threads were stripped/worn.Due to the stripped condition of the threads, the coded functional issue was confirmed.Although no definitive root-cause can be determined, the set screw may have experienced unintended forces such as over-torque during implantation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: 5.5 EXP VERSE UNITIZED SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9104264
• MDR Text Key: 159662306
• Report Number: 1526439-2019-52121
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466149
• UDI-Public: (01)10705034466149
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• 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,Followup
• Report Date: 08/27/2019

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 Catalogue Number: 199721001S
• Device Lot Number: VH1233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 10/01/2019; 11/14/2019; 02/05/2020; 04/24/2020
• Supplement Dates FDA Received: 10/28/2019; 11/14/2019; 02/26/2020; 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention