MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for 2ea.Unknown screws uss vas scaral screws that were too difficult to remove and remain implanted in the patient.Unknown lot number.Original implant date unknown.Device is expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: patient presented in the or with previous instrumented fusion at l4/5 and l5/s1.The reason and date/year for original fusion is unknown.Patient was originally implanted with posterior lumbar fusion using universal spinal variable axis screw system (uss vas).On (b)(6) 2015, patient was scheduled for revision surgery with l3-l4 posterior fusion with interbody fusion using uss hardware due to degenerative disc disease at the l4 level.During revision surgery, surgeon attempted to remove all previous construct implants, but 2 screws at the s1 level were too difficult to remove and remain implanted in the patient.Surgeon removed the other 4 sacral screws, two rods, 6 collars, and 6 nuts.While the surgeon was attempting to remove the sacral screws at an unknown disc level the hex driver tip broke off.A fragment was generated.Fragment was retrieved and disposed of by the hospital.Revision fusion surgery was completed successfully.Another instrument was available and procedure was completed with no reported surgical time extension.This report is 4 of 7 for (b)(4).

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5135982
• MDR Text Key: 27776188
• Report Number: 2520274-2015-16487
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR