MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186715000

Device Problem Unstable Capture Threshold (3269)

Patient Problems Tissue Damage (2104); Blood Loss (2597); Not Applicable (3189)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The mis single inner set screw was returned to the complaint handling unit (chu).The returned set screw features a variety of different witness marks, most of which are irregular witness marks.Typically, set screw witness marks are light, symmetrical marks on opposing sides of the bottom of the set screw that start as a sweeping scuff mark across its face and end in an indent.The returned set screw does not feature such markings.Although there are markings of some kind featured on the set screw, they vary significantly.All of the witness marks are some variation of shallow, asymmetrical, and irregular.The markings on the returned set screw is not indicative of the set screw correctly coming into contact with and being tightened down onto the associated rod.The set screw may have not been properly tightened down on top of the associated rod.This may have permitted the rod to migrate.A device history record review did not find any issues that caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the set screws loosening could not be determined by the sample or information provided.A potential root cause may be the set screw not being correctly tightened down onto the rod properly.This may have allowed the rod to migrate.No issues could be identified in the manufacturing or release of these products.Therefore, this complaint 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.

Event Description

It was reported that the pedicle screw of l4 left couldn't stabilize the rod.

• Brand Name: MIS SINGLE INNER SETSCW
• 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 INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7949078
• MDR Text Key: 123195534
• Report Number: 1526439-2018-50966
• Device Sequence Number: 1
• Product Code: NKB
• 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
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 186715000
• Device Lot Number: 198019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 75