MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI OFFSET LAMINA HOOK LOW PROFILE-LEFT; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.261

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 12/19/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the fall of the veptr hook occurred.Following the previous surgery to carry out the replacement of the veptr implant, the patient started complaining of pains post-operatively.Although the pain totally disappeared later by the time when the patient had visited the hospital afterwards, it transpired that the lamina hook had been migrating to the l4 area from the l3.The surgeon has surmised that the hook had fallen because of undue physical stress of veptr.Allegedly, the patient is not in pain currently after having experienced unknown pains for about 3 consecutive days.Another revision is due to take place on (b)(6) 2015, in an attempt to perform screw fixation after removing the hook on the lumber vertebra side.The dislocated hook seems to have migrated to somewhere between the bones, but fortunately now the patient is in stable condition.Even so, the patient is still under close observation for the upcoming surgery.This report is 1 of 1 for (b)(4).

Event Description

This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.

Manufacturer Narrative

A review of the device history records has been requested.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.

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.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.

Manufacturer Narrative

Additional narrative: patient identifier and weight are unknown.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.

Manufacturer Narrative

A manufacturing investigation was performed for the subject device (part number 497.261, ti offset lamina hook low profile-left, lot number 7773245).The subject device was received with visible scratches, marring, and discolored and/or missing anodite on the various surfaces of the part.These features were observed during a macroscopic examination under laboratory lighting and were determined to be indicative of post manufacturing use and/or explant.The subject device features were evaluated and measured to verify the device dimensions were within the specifications depicted on the associated product drawings.The results of verification of all potentially relevant features found that all features were manufactured to be within the specified limits.Therefore, there is no objective evidence supporting the notion that manufacturing of the reported product is relevant to the complaint condition reported as¿ implant failure postoperatively: migrated.¿ the root cause of the complaint condition could not be identified based on the reported information and the investigation of the returned device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history record(s) of the reported product lot, sub-components, and raw material from which it was produced showed that there were no nonconformities reported for the raw material or during the manufacture of the reported product lot that would contribute to the complaint condition reported as implant failure postoperatively.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI OFFSET LAMINA HOOK LOW PROFILE-LEFT
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4447620
• MDR Text Key: 5388751
• Report Number: 2520274-2015-10535
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.261
• Device Lot Number: 7773245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR