MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SPS SMALL FRAGMENT T-PLATE STAINLESS STEEL; IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Irritation (1941)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a post-market clinical follow-up (pmcf) from university hospitals (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the internal fracture fixation of long bones with the stryker plating system (sps)¿ which was published in june 2019 and is associated with the stryker plating system (sps).Within that publication, post-operative complications/ adverse events were reported which occurred between july 2014 to july 2018.It was not possible to ascertain specific device or patient information from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 22 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses prominence of metalwork.4 out of 4 cases.Removal of hardware due to prominence and irritation of the soft tissue the pmcf report states, ¿cloverleaf applied to the medial malleolus of the tibia for a vertically oriented shear fracture, the fracture united and was subsequently removed due to prominence and irritation of the soft tissue at 228 days post implantation.The patient remains under follow up but radiographically a good outcome has been achieved.[¿] prominence of metalwork is in the authors experience often more likely due to patient factors than the design of the plate¿.

• Brand Name: UNKNOWN SPS SMALL FRAGMENT T-PLATE STAINLESS STEEL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8847406
• MDR Text Key: 152908172
• Report Number: 0008031020-2019-00968
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2019

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 07/31/2019
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention