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

Model Number 179702000

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Spinal Column Injury (2081); Not Applicable (3189)

Event Date 08/26/2018

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 the tlif surgery was performed on (b)(6) 2018 to fix l2-l3 left.Then, after the primary surgery, the patient complained back pain, so that the patient visited to see the surgeon on (b)(6) 2018.Then, the surgeon found that the l2 left set screw was disassociated, and the cage was backout, so that the removal surgery was performed to explant l2 left and l3 left set screw.The surgeon requested to investigate not only l2, but also l3 set screw.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.

Manufacturer Narrative

(b)(4).Visual examination of the single-inner setscrew revealed signs of operative use as evidenced by superficial markings, with threads and drive feature slightly worn.Rod striations were observed on the set screws suggesting that the set screw was seated and tightened properly.The exact part and lot number combination is unknown as the lot # from the returned set screw was not legible; therefore, the manufacturing or receiving inspection records could not be reviewed all complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the loosening of the single-inner setscrew cannot be determined.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 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 and no systemic trends were found, 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.

• Brand Name: SINGLE-INNER SETSCREW
• 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: 7949549
• MDR Text Key: 123190059
• Report Number: 1526439-2018-50972
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

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 Model Number: 179702000
• Device Catalogue Number: 179702000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 48 YR
• Patient Weight: 35