MAUDE Adverse Event Report: SYNTHES USA 8.0MM TI MATRIX SCREW 40MM THREAD LENGTH; ORTHOSIS, SPIINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.639.840

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  Injury  

Manufacturer Narrative

(b)(6).Although event date was given, it is truly unknown as (b)(6) 2017 was the date of the planned revision surgery date and not the date the patient experienced pain and/or screws backed out.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that the patient had original surgery on (b)(6) 2015 at l4-l5 disc levels.During surgery patient was implanted with four (4) matrix screws, four (4) matrix polyaxial heads, four (4) matrix locking caps and two (2) pre-contoured rods.Post- operatively patient presented with pain.It was discovered on x-rays on an unknown date that the four (4) matrix screws were loose and had backed out.Surgeon reported that the construct was unstable.Revision surgery was performed on (b)(6) 2017.During revision, all original implants were removed intact and the patient was revised with larger diameter matrix implants.Patient is reported as being stable.Surgery was completed successfully with no surgical delay.Concomitant devices reported: ti matrix locking cap (part number: 04.632.000, quantity: 4), ti matrix top loading polyaxial head (part number: 04.632.001, quantity: 4) 5.5 mm pre-contoured rod 40 mm (part number 09.636.040, quantity 2).This is report 2 of 4 for (b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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.A manufacturing investigation was performed for the subject device (8.0mm ti matrix screw 40mm thread length, part number 04.639.840, lot number unknown).The subject device was returned to the manufacturer with the complaint condition stating: the screw with body assembly attached was received functioning as designed with screw capable of full 360° articulation.There is no requirement for dis-assembly; no relevant dimensions are hidden by product being assembled.Since all features relevant to complaint condition have passed dimensional inspection, and product performs as designed, complaint is unconfirmed.A product development investigation was performed for the subject device (8.0mm ti matrix screw 40mm thread length, part number 04.639.840, lot number unknown).The subject device was returned with the complaint condition stating: the four (4) bone screws were returned assembled to the polyaxial head (part 04.632.001, lot 9849894, qty 4).These polyaxial heads are sold separately from the bone screws but the reported part numbers were able to be verified upon arrival using caliper (40mm ¿ 04.639.840 qty2, 45mm ¿ 04.639.845 qty 2).The stardrive recess of all screws were slightly scratched and dented consistent with wear from insertion/extraction.Post manufacturing wear marks were evident predominantly around the neck of the bone screws but scratches and anodization wear was also found along the shafts.Relevant features for all parts passed inspection during a manufacturing evaluation.The complaint condition of postoperative loosening could not be confirmed with the provided information therefore a definitive root cause could not be determined.Although a definitive root cause could not be determined, multiple factors including surgical technique, biomechanical loading, and excessive impact can lead to postoperative loosening of the construct.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, manufacturing investigation, complaint history review, and risk assessment review were performed as part of this investigation.A device history records (dhr) review could not be performed as the lot numbers of the bone screws were not provided.This complaint is unconfirmed.The following parts were returned as concomitant devices without an alleged complaint condition: ti locking cap: 04.632.000, lots 7398428 (qty 1), 9832701 (qty 2), 9823836 (qty 1) rods ø5.5mm, 40mm: 09.636.040, lot 9706335 (qty 2).Upon visual inspection there is no definitive evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on the devices.The rods have visual damage (polished areas-blast texture missing).Lot 7398428 of the locking caps has post-manufacturing wear on one side of the grooves only.One (1) of lot 9832701 had greater wear (compared to 7398428) on both sides of the grooves.This wear is consistent with the rods rubbing against the locking caps.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 8.0MM TI MATRIX SCREW 40MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPIINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6489869
• MDR Text Key: 72735746
• Report Number: 2520274-2017-11273
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.639.840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PART NUMBER 09.636.040, LOT NUMBER UNK, QTY: 2; PART NUMBER: 04.632.000, LOT NUMBER: UNK, QTY: 4; PART NUMBER: 04.632.001, LOT NUMBER: UNK, QTY: 4
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 86