MAUDE Adverse Event Report: SYNTHES USA 6.0MM TI COLLAR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Unknown when non-union, pain, discomfort or irritation occurred.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and 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 is reported patient was implanted with synthes uss (universal spine system) at l5-s1 approximately 1 year prior.Patient did not heal and a non-union exists at that level.Patient was returned to or on (b)(6) 2016 where surgeon first removed a mtf t-plif spacer from the l5-s1 disc space and performed an alif with a mtf fra allograft.Patient was then repositioned to prone for the posterior revision.Surgeon removed all of the uss hardward at l5-s1 and placed new uss screws and upsized the screw diameters by one mm for each screw.New rods were then placed and the procedure was completed successfully with no delay or harm to patient.There is no allegation against the explanted hardware.This report is 10 of 13 for (b)(4).

• Brand Name: 6.0MM TI COLLAR
• 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: 5411700
• MDR Text Key: 37518199
• Report Number: 2520274-2016-10816
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR