MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI CRADLE END HALF; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.126

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient weight not provided by reporter.(b)(4).Without a lot number the device history records review could not be completed.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

Device report from synthes (b)(4) reports an event in japan as follows: in 2010 a vertical expandable prosthetic titanium rib (veptr) system was initially implanted to the rib-l for the treatment of thoracic insufficiency syndrome (tis).A replacement operation was performed on (b)(6), 2014, followed by a lengthening operation on an unknown date.When the patient had a postoperative follow-up, it was found that the patient had dislocation of the cranial rib support.To avoid the patient's tis worsening, an operation was performed on (b)(6), 2015.During the operation, any trace of the brakeage of the rib where the cranial rib support was attached could not be found thus leaving question for how the dislocation occurred.Patient is reportedly very active and moved around freely in her daily life, it was suspected that the rib support may have dislocated while the patient was moving around.The reported cranial rib support was replaced with another cranial rib support (veptr ii) during the vision surgery.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device history record review: manufacturing location: (b)(4).Manufacturing date: 23september2011.Part: 497.126, lot: 6741875 (non-sterile) - ti cradle end half.Lot was release to the warehouse on 23september2011.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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

Product investigation summary: two relevant construct components were returned: neutral 220mm superior cradle (part 497.057 / lot 6714005) and a cradle end half (part 497.126 / lot 6741875).The returned implants were examined; minor surface scratches and anodization wear consistent with implantation and explantation were present on both devices.No additional defects were noted.Additional construct components were returned: titanium rib sleeve (part 497.111 / lot 6905269), distraction lock x2 (part 497.125 / lots 7544298 and 7544305), cradle lock (part 497.128 / lot 6641738), and lumbar extension (part 497.253 / lot 6033396).No specific allegation was made against these components; as such no investigation is necessary.The superior cradle and cradle end half are components of veptr system instrument and implant set, which is utilized in veptr procedures to mechanically stabilize and distract the thorax to correct three-dimensional thoracic deformities.The superior cradle and cradle end half are specifically utilized as the superior point of attachment for the construct.After both components are in place and aligned, they are locked with a cradle lock to ensure the assembly is secure and fully encircles the rib.The relevant drawings for the returned instrument were reviewed.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot numbers and in each instance no material record reports, non-conformance reports, or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.No definitive root cause was able to be determined with the provided information.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.

• Brand Name: TI CRADLE END HALF
• 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: 5081462
• MDR Text Key: 25965316
• Report Number: 2520274-2015-15905
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.126
• Device Lot Number: 6741875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR