MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI MATRIX TOP LOADING POLYAXIAL HEAD; ORTHOSIS, SPINAL PEDICLE FIXATION FOR DDD

Catalog Number 04.632.001

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

It was reported that approximately 6 months prior to (b)(6) 2015, the patient had l4-s1 fusion surgery.The patient returned to operating room on (b)(6) 2015 for revision surgery due to hardware loosening and migration of a non-synthes implant.Reportedly, the patient had pain associated with these events.A preoperative x-ray showed the head of a matrix screw had popped off at l4.Reportedly, that event lead to loosening which lead to migration of the non-synthes implant.Two matrix screws (including the one with the broken head) were removed during the revision.The patient was re-instrumented with expedium.There was no reported surgical delay and no fragments left behind during the revision procedure, which was successfully completed.This report is 2 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient id #(b)(6); patient age not reported; patient weight not reported.Unknown when pain first occurred.Additional product codes: mnh, mni, kwq, kwp.Date of original surgery was approx.6 months prior to (b)(6) 2015.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional 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.

Manufacturer Narrative

Device 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.

Event Description

This report is 2 of 5 for (b)(4).

Manufacturer Narrative

Product investigation summary: the returned polyaxial head (04.632.001 / lot 1980448), 7.0mm matrix screw (04.639.740), and locking cap (04.632.000 / lot 7809312) were examined and typical wear associated with implantation and explanation were present (i.E.Worn adonization, nicks/gouges on polyaxial head).As no allegation was made against the screw body or locking cap, no further evaluation will be completed.The collet material and bone screw/collet interface were found adequate and likely did not contribute to the broken collet condition.Possible factors that may have caused the polyaxial head to ¿pop off¿ include: not removing all interfering bone before the polyaxial head is assembled to the screw, using excessive assembly force, or misusing the instruments intended to assemble the head to the screw.The user technique is not known, so an exact root cause cannot be determined.The matrix top loading polyaxial head is utilized in both assembled polyaxial reduction screws and individually for use in unassembled pedicle screw insertion.The system technique guide notes that after screw insertion, a reamer (03.632.046) is placed over the implanted screw and rotated, removing interfering bone to ensure sufficient space exists for the polyaxial head.If this step was not completed prior to attempted assembly, the complaint condition of ¿migrated¿ could result.Excessive assembly force or misuse of placement instruments may have also resulted in the complaint condition.As specific technique of the user is was not reported a definitive root cause cannot be determined.Reduction head drawings were reviewed during the investigation.The bone screw/collet interface is designed with an interference fit in order to prevent a failure mode of sudden loosening when the screw is over tightened to the bone.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Device 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.

Event Description

(b)(4).

• Brand Name: TI MATRIX TOP LOADING POLYAXIAL HEAD
• 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: 4913672
• MDR Text Key: 15893260
• Report Number: 2530088-2015-10511
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2015

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: Health Professional
• Device Catalogue Number: 04.632.001
• Device Lot Number: 7980448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 07/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/16/2015; 07/20/2015; 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention