MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179702000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgery took place (b)(6) over four levels with augmented cfx screws.At postop xray control on (b)(6), it was noted that two innies had opened completely and one rod was out of the screws.Revision surgery took place on (b)(6), screws were left in place as the screws itself seemed perfectly intact, four new innies were used for the affected rod.

Manufacturer Narrative

(b)(4).The four single inner set screws (product code: 1797-02-000, lot numbers: avfcjr (2), avgbt9, avcftc) were returned to the customer quality unit (cqu) on december 9th, 2016.All four set screws featured some signs of use in the form of superficial surface markings.It was notable that there are tightening witness marks on only two of the returned set screws.These marks are associated with the set screw being properly tightened down onto the rod to such a degree that the set screw will not loosen and back out from its position on the rod.Two set screws, one from lot avgbt9 and the other from lot avfcjr, do not feature any witness marks at all.It is believed that these two set screws were the ones to back out postoperatively while the other two remained in place.The screws with witness marks are considered to be concomitant due to the likelihood that the remaining two backed out postoperatively.The root cause of the set screws loosening could not be determined by the samples or information.A potential root cause may be the set screws not being fully tightened down onto the rod.This could potentially allow the set screws to loosen postoperatively.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): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6145218
• MDR Text Key: 61437329
• Report Number: 1526439-2016-10896
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142460
• 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: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 179702000
• Device Lot Number: AVFCJR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention