MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH IEXP DDV TI SLOTTED CONN EXT; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 175450020

Device Problem Migration (4003)

Patient Problem Spinal Column Injury (2081)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

It was reported that dr (b)(6) informed us of another connector which had moved post-operatively.On (b)(6) 2018: initial procedure (overview of used product can be found in the attachments).On (b)(6) 2018 a ct was taken (post-op), because of sudden outage of the left leg.The connector was still well positioned.On (b)(6) 2008 a rx was taken and it became clear that the connector had moved (ct and rx can be found in th attachments).Revision took place on (b)(6) 2008.Defective implants will be returned for analysis.

Manufacturer Narrative

(b)(4).Device was not returned for evaluation.A photocopy of the x-ray was provided which revealed the loosening and migration of the reported connector extension.A review of the device history record could not be performed as the lot number is unknown.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause cannot be determined with the information provided.In general, patient factors that may affect the performance of the components include patient anatomy, bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history.Rehabilitation protocol and adherence thereto are unknown.As no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IEXP DDV TI SLOTTED CONN EXT
• 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
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7836717
• MDR Text Key: 118880335
• Report Number: 1526439-2018-50820
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034251707
• UDI-Public: (01)10705034251707
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175450020
• Device Catalogue Number: 175450020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention