MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER MONO SCREW 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186717640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention, pain, medical device removal.(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 or Problem Description
Hospital - (b)(6).Date of complaint - (b)(6) 2019.Made aware - (b)(4) 2019.Present in theatre - yes.Delay in procedure - none.Impact to patient - pain leading to planned revision procedure.Product code (1)- 186717640 x 4, lot no.Unknown at this time.Product code (2) - 186715640 x 2.Product code (3) - rod, code/lot no unknown.Product code (4) - 186715000 x 6, lot no.Unknown at this time.Am i in possession - awaiting sterilisation/decon certificate.What happened - revision surgery to remove metalwork.Revision / hardware removal.Date of original implant: approx 12 months.Was device explanted (yes or no): yes.If yes, date of explant: (b)(6) 2019.Revision due to: pain, broken metalwork (pedicle screws).Hardware removal due to: broken metalwork - distal 2 pedicle screws.This complaint involves thirteen (13) devices.
Additional Manufacturer Narrative
Product complaint (b)(4).Udi (b)(4).Visual examination of the device revealed significant signs of use such as surface markings.No damage was found with the device.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.A root cause analysis is not required as there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a depuy synthes device after it was released for distribution; and there is no report of an adverse event involving a depuy synthes device.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.
Additional Manufacturer Narrative
(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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
The initial complaint was reviewed and found not reportable.It was determined there was no reported or identified malfunction of the device.
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.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.It was determined there was no reported or identified malfunction of the device.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: VIPER MONO SCREW 6X45MM TI
• Common Device Name: 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: 8861376
• Report Number: 1526439-2019-51926
• Device Sequence Number: 1829232
• Product Code: NKB
• UDI-Device Identifier: 10705034123462
• UDI-Public: (01)10705034123462
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/11/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186717640
• Device Catalogue Number: 186717645
• Device Lot Number: RL255359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 08/08/2019; 02/05/2020; 02/21/2020
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/23/2019; 10/11/2019; 02/05/2020; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention