MAUDE Adverse Event Report: SYNTHES USA MATRIX LOCKING CAP WITHOUT SADDLE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 09.632.099

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/13/2015

Event Type  malfunction  

Event Description

It was reported that during surgery for a posterior lumbar fusion (tlif) at l5-s1 level, surgeon noted that the matrix locking cap would not tighten down and continued spinning on top of the matrix polyaxial screw at the l5 right level.Two locking caps, polyaxial screws and one rod was removed and replaced.All implants were doubled checked and the case was completed without further incident.No reported fragments left behind.Due to this event an additional 5 minutes was added to operating room time.Surgery was completed successful.Broken cap and screw are reportable items.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: no patient data reported.Additional product codes: mnh, mni, kwq, kwp.Implant/explant date: unknown.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.

Manufacturer Narrative

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: MATRIX LOCKING CAP WITHOUT SADDLE
• 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: 4734969
• MDR Text Key: 16069150
• Report Number: 2520274-2015-13480
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.632.099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 04/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2015
• 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