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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 5.5MM TI HARD ROD 300MM ORTHOSIS, SPINAL PEDICLE, FIXATION, FOR DDD

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SYNTHES USA 5.5MM TI HARD ROD 300MM ORTHOSIS, SPINAL PEDICLE, FIXATION, FOR DDD Back to Search Results
Catalog Number 04.633.293
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Muscle Spasm(s) (1966); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient dob, gender & weight not provided by reporter. Additional classification codes are mnh, mni, kwq and kwp. This report is for unknown rod/unknown lot number. Udi: unknown part number, unknown lot number, udi is unavailable. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. (b)(4). The 510k#: unknown. Subject device has not been received. 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.
 
Event Description
It was reported that a patient underwent a posterolateral spinal fusion from t7-8 through l1-2 using the matrix spine system, on (b)(6) 2012. This was an extension of previous a fusion from l2 to s1. Initial hardware implanted was a competitor steel construct. On (b)(6) 2013, the patient underwent surgical revision due to acute pain and instability in the thoracic and lumbar spine. It was found that the left titanium rod fractured at the junction of l1 to l2 where the matrix instrumentation and existing construct met. The patient also had complaints of muscle spasms, mental anguish , insomnia, as well as anxiety and apprehension about his mental and physical condition. No additional information was available. This complaint involves 1 (one) device. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
On (b)(6) 2016 updated information for surgical and medical records that was reviewed; complaint updated with additional procedure details, patient information, surgeon information, relevant tests and lab data was updated. Concomitant medical products: therapy dates vary: from (b)(6) 2012 thru (b)(6) 2013 for unknown part #, unknown lot # and unknown quantity. (b)(6). Device is not expected to be returned to synthes manufacturer for evaluation /investigation, 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
Update: during the (b)(6)2012 surgery, the new titanium matrix system that was implanted from t7 - l2 which was connected to the previously implanted (non-synthes) stainless steel system with a synthes domino connector (parallel connector). Postoperative imaging confirmed device placement. The construct failed approximately 2 month prior to the revision surgery on (b)(6) 2013. The patient was having significant pain. The left side 5. 5mm titanium rod broke and that the domino connector that had connected the stainless steel system into the titanium system pulled off the stainless steel rod. During the (b)(6) 2013 revision surgery all of the hardware, stainless steel and titanium were removed. It was reported on the surgical record that it took an abnormally long amount of time to remove the previously implanted (non-synthes) stainless steel system. It was also reported that the synthes titanium screws were in good position and that none had backed out. The (b)(6) 2013 revision surgery was removal of segmental instrumentation, t7 - s1, implantation of segmental instrumentation, t7 - s1, revision arthrodesis t7-8, t8-9, t9-10, t10-11, t11-12, t12-l1, l1-l2, l2-3, l3-4, l4-5 and l5 - s1. Intraoperative fluoroscopy and o arm ct was performed, iliac crest bone marrow harvest, auto graft and allograft. There were no reported complications with the surgery. This complaint involves 2 device. Concomitant devices: unknown pedicle screws, unknown part #, unknown lot # and unknown quantity. Unknown screw caps, unknown part #, unknown lot # and unknown quantity. Unknown cross linking adaptors, unknown part #, unknown lot # quantity(b)(4). Unknown 5. 5mm rod, unknown part #, unknown lot # quantity (b)(4). Unknown non synthes stainless steel construct at l2 to s1 unknown part #, unknown lot # and unknown quantity. This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
Other device product code use: mnh, mni, kwq, kwp. (b)(4). Therapy dates vary: from (b)(6) 2012 thru (b)(6) 2013. 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
Reported medical reports were reviewed by manufacturer. Concomitant medical products: matrix polyaxial screws 5. 0mm x 45mm (part #04. 632. 545, lot #unknown, quantity 2); matrix polyaxial screws 6. 0mm x 45mm(part #04. 632. 645, lot #unknown, quantity 2); matrix polyaxial screws 7. 0mm x 55mm (part #04. 632. 755, lot #unknown, quantity 2); matrix polyaxial screws 8. 0mm x 55mm (part #04. 632. 855, lot #unknown, quantity 5); matrix polyaxial screws 8. 0mm x 60mm (part #04. 632. 860, lot #unknown, quantity 1); ti matrix locking cap (part #04. 632. 000, lot #unknown, quantity 12); ti hard rod 5. 5mm x 300mm (part #04. 633. 293, lot #unknown, quantity 2); ti snap-on open parallel connector (part #04. 633. 404, lot #unknown, quantity 1); ti snap-on transconnector (part #04. 633. 338, lot #unknown, quantity 2); non-synthes stainless steel construct at l2 to s1 (part #unknown, lot #unknown, quantity unknown).
 
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 1 of 2 for (b)(4).
 
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Brand Name5.5MM TI HARD ROD 300MM
Type of DeviceORTHOSIS, SPINAL PEDICLE, FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5551950
MDR Text Key42005381
Report Number2520274-2016-11991
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100952
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.633.293
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/06/2016 Patient Sequence Number: 1
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