MAUDE Adverse Event Report: SYNTHES BRANDYWINE 5.5MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.140

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional device codes: mnh, mni, kwq, kwp.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4) used for: the head of the screw came off which required a revision.A review of the device history records has been requested.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 a surgeon performed the original scoliosis surgery on (b)(6) 2014.The construct was a full scoliosis t10 pelvis.During a follow up, surgeon noticed that the left iliac wing screw was problematic.Specifically, the head of the screw came off from the matrix screw shaft at the left iliac wing.This resulted in a revision surgery which was performed on (b)(6) 2016.There was surgical delay of unknown duration.No intra-operative device malfunction was reported and no patient harm was reported.Patient was stable post-operatively.This complaint involves one device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Therapy date of concomitant device is unknown.Device history records review was completed for part# 04.632.140, lot# 7438122.Manufacturing location: (b)(4), manufacturing date: jul 22, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

Concomitant devices reported: locking cap (part # unknown, lot # unknown, quantity # 1), rod (part # unknown, lot # unknown, quantity # 1).

Manufacturer Narrative

A product development was performed on the returned device (5.5mm ti matrix polyaxial screw 40mm thread length, part # 04.632.140, lot # 7438122).The returned screw and polyaxial head were not attached when returned.The bead blasted portion of the head of the screw was found to be damaged, with a section of the surface worn smooth.Additionally the screw head has dents and deformation at the top of the head.The polyaxial head is deformed on the underside where the screw comes through the device.The polyaxial head also has signs of surface wear which does not impact functionality.The screw and polyaxial head were able to be reassembled during investigation, and were not able to be separated by hand.A visual inspection, drawing review, and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed.Once the device was re-assembled the complaint was not able to be replicated.The matrix polyaxial screw (04.632.640) is utilized in matrix deformity and matrix degenerative as part of the posterior pedicle screw and rod fixation system.Polyaxial screws are available in 4.0mm, 5.0mm, 5.5mm, 6.0mm, 7.0mm, 8.0mm and 9.0mm diameters and lengths ranging from 20-100mm.The drawings for 5.5mm matrix ti screw and matrix spherical head were reviewed during investigation.The diameter of the matrix screw head was measured and found to be within specification.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.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: 5.5MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6149834
• MDR Text Key: 61591638
• Report Number: 2530088-2016-10338
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2016

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: Health Professional
• Device Catalogue Number: 04.632.140
• Device Lot Number: 7438122
• Other Device ID Number: (01)0705034745084(10)7438122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2017; 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR