MAUDE Adverse Event Report: DEPUY SPINE INC ISOLA SPINE SYSTEM DUAL CONNECTOR JAW 6.35 - 6.35MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 203014

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a coronary artery bypass graft (cabg) the device broke.Another device was used to complete the procedure.This report involves one (1) isola spine system dual connector jaw 6.35 - 6.35mm.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Additional device product codes: kwq, kwp, and mni.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: ISOLA SPINE SYSTEM DUAL CONNECTOR JAW 6.35 - 6.35MM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12802807
• MDR Text Key: 284034230
• Report Number: 1526439-2021-02380
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034000978
• UDI-Public: (01)10705034000978
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K980485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 203014
• Device Catalogue Number: 203014
• Device Lot Number: T011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: IS DUAL TRC 1/4-1/4 SS; IS DUAL TRC 1/4-1/4 SS