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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BRANDYWINETI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 68MM(60MM)

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SYNTHES BRANDYWINE TI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 68MM(60MM)   Back to Search Results
Catalog Number 487.356
Event Date 10/25/2012
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4): a device history record review was conducted. Mrrs nonconformance associated with the part are not relevant to the complaint condition. No other discrepancies were noted that would be associated with this complaint. A manufacturing evaluation was conducted. The plate was received with anodize discoloration and nicks/scratches on top and bottom of part and nicks/scratches in d2 holes. Bone in-growth is visible on the screw included in the bag with the plate. All described nonconformities are post manufacturing. All readings for the raw material were acceptable. The cslp plate performed as designed, patient fused with good outcome. (b)(4): placeholder.

 
Manufacturer Narrative

Device was used for treatment. The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system. Without a lot number the device history records review could not be completed.

 
Event Description

Patient was implanted with ti cervical spine locking plate and screws to the cervical spine at c4-c7 on (b)(6) 2010. The patient returned for a routine follow-up and x-rays were taken. The surgeon noticed two of the cslp screws were broken. Reportedly one screw was broken mid shaft and the other screw was broken a few threads below the head of the screw. The surgeon decided to remove all of the hardware. Patient was returned to the operating room on (b)(6) 2012, for removal of one plate and sixteen screws. Patient was not revised with any additional hardware as the patient was fused and the surgeon was satisfied with the outcome. The procedure was completed successfully. This is 3 of 3 reports for the same event.

 
Manufacturer Narrative

Device used for treatment and not diagnosis. Based on the information provided, it will not be possible to determine what the cause of the malfunction was. The breakage likely happened before the patient fused, but there is nothing that indicates the design contributed to it. There may have been some excessive strain by the patient or other excessive forces on the construct. The design risk assessment is adequate for the intended use.

 
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Brand NameTI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 68MM(60MM)
Type of DevicePLATE
Manufacturer (Section F)
SYNTHES BRANDYWINE
1303 goshen parkway
west chester PA 19380
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
sarma pin
1302 wrights lane east
west chester , PA 19380
(800) 620 -7025
Device Event Key2869115
MDR Report Key2842745
Event Key2739300
Report Number2530088-2012-01027
Device Sequence Number1
Product CodeKWQ
Report Source Manufacturer
Source Type Company Representative,Health Professional
Reporter Occupation Other
Type of Report Followup,Initial
Report Date 10/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number487.356
Device LOT Number4983895
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/06/2012
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/04/2013
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 11/21/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
SCREWS
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