MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, CERVICAL PEDICLA SCREW SPINAL FIXATION

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Aditional product code: kwp.Device not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).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

Device report from synthes on an event in (b)(6) as follows: it was reported that post-operative the cervifix occiput rod broke.The implantation was performed on (b)(6) 2016.It was decided to add a second part for an unknown rod that was broken post-operatively too as it was visible on the x-rays.No information available about patient condition, outcome or if a revision surgery was performed.The surgeon did not perform a revision surgery yet.This complaint involves 2 parts.Concomitant medical products: 5x locking cap (part and lot unknown); 5x pedicle screw (part and lot unknown); 1x locking screw axon (part 406.104 lot 9824135); 3x cortex screw (part and lot unknown); 3x cortex screw (part 404.310 lot 9401671, part 404.310 lot 3277548, part 404.312 lot 9789709).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This report is for one (1) unknown rod.Part and lot numbers are unavailable for reporting.Other number¿udi: part number unknown, udi is unavailable.Additional device product codes are mnh, mni and kwq.510(k): a 510(k) number was reported in error in the initial medwatch report #(b)(4).A 510(k) number cannot be identified without a part number.This field should have remained blank as the 510(k) number is unknown.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.

• Type of Device: ORTHOSIS, CERVICAL PEDICLA SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6473413
• MDR Text Key: 72173241
• Report Number: 2520274-2017-11228
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• 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?: Yes
• Date Manufacturer Received: 04/10/2017
• 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: 1X LOCKING SCREW AXON (PART 406.104 LOT 9824135); 3X CORTEX SCREW (PART 404.310 LOT 9401671; 3X CORTEX SCREW (PART AND LOT UNKNOWN); 5X LOCKING CAP (PART AND LOT UNKNOWN); 5X LOCKING CAP (PART AND LOT UNKNOWN); PART 404.310 LOT 3277548; PART 404.312 LOT 9789709
• Patient Outcome(s): Required Intervention