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

Catalog Number 09.632.099

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product codes are mnh, mni, kwq and kwp.(b)(4).The subject device has been received and is currently in the evaluation process.A device history record review has been requested.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 that a patient had a deformity correction from t3 to l3 using matrix construct on (b)(6) 2015.Initial surgery was successfully completed without complications.A follow-up x-ray on unknown date revealed that a locking cap (09.632.099) has completely dislodged (free-floating) from the original location.It was noted that in the x-ray, the rod appears to be on top of the screw head.The patient had a revision surgery on (b)(6) 2015.The rod was re-bent and the locking cap was replaced.The surgeon believed that he did not bend the rod enough during the initial surgery.The same screw was used.The patient is in stable condition.Revision surgery was successfully completed without surgical delay.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Manufacture date: may 01, 2015.Review of the device history records showed there were no issues during the manufacture that would contribute to this complaint condition.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (matrix locking cap without saddle, part number 09.632.099, lot number 9800704).The subject device was returned with the complaint that the locking cap was discovered dislodged from the original location during a follow-up x-ray.The locking cap is used in the matrix spine degenerative system (036.001.185) and matrix spine mis instrumentation set (036.001.190).The implant is used to lock the rod in place within the polyaxial screw head.The product drawing was reviewed during the investigation during the investigation and was found suitable to determine the intended device design, application, and dimensional conformity.The subject device was received with no visible damage.The subject device met dimensional and functional conformity when measured and tested against a model matrix polyaxial screw head and rod.The functionality of the locking cap was tested by using a functioning t25 stardrive shaft, polyaxial matrix screw, and 5.5mm rod.The locking cap was able to be inserted without resistance and securely held the rod in place.It is likely that the cause of error was related to user technique.The reporter did mention that the surgeon believed that he did not bend the rod enough during the initial surgery.Another possible root cause is that locking cap was not fully tightened during the initial surgery.A definitive root cause could not be determined.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 BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5372238
• MDR Text Key: 36228248
• Report Number: 2530088-2016-10009
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.632.099
• Device Lot Number: 9800704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 70